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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00910962
Registration number
NCT00910962
Ethics application status
Date submitted
28/05/2009
Date registered
1/06/2009
Date last updated
7/12/2017
Titles & IDs
Public title
A Study to Evaluate the Safety of 12 Weeks of Dosing With GW856553 and Its Effects on Inflammatory Markers, Infarct Size, and Cardiac Function in Subjects With Myocardial Infarction Without ST-segment Elevation
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Scientific title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 12 Weeks of Dosing With GW856553 and Its Effects on Inflammatory Markers, Infarct Size, and Cardiac Function in Subjects With Myocardial Infarction Without ST-segment Elevation
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Secondary ID [1]
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111810
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Universal Trial Number (UTN)
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Trial acronym
Solstice
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GW856553
Treatment: Drugs - GW856553
Treatment: Drugs - Placebo
Experimental: Treatment A - 7.5 mg GW856553 starting dose, followed 12 hours later by 7.5mg twice daily for 12 weeks
Experimental: Treatment B - 15 mg GW856553 starting dose, followed 12 hours later by 7.5mg twice daily for 12 weeks
Placebo Comparator: Treatment C - Placebo twice daily for 12 weeks
Treatment: Drugs: GW856553
7.5 mg GW856553 starting dose, followed 12 hours later by 7.5mg BID
Treatment: Drugs: GW856553
15 mg GW856553 starting dose, followed 12 hours later by 7.5mg BID
Treatment: Drugs: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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AE was any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
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Timepoint [1]
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Up to Week 14
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Primary outcome [2]
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Number of Participants With Any Major Adverse Cardiovascular Events (MACE)
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Assessment method [2]
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MACE was defined as all-cause death, adjudicated myocardial infarction, stroke/transient ischemic attack, heart failure or recurrent ischemia requiring urgent revascularization.
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Timepoint [2]
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Up to Week 14
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Primary outcome [3]
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Number of Participants With Any Pure MACE
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Assessment method [3]
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Pure MACE was defined as all-cause death, adjudicated myocardial infarction or stroke/transient ischemic attack.
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Timepoint [3]
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Up to Week 14
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Primary outcome [4]
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Number of Participants With Hematology Data of Potential Clinical Importance (PCI) at Any Visit Post-Baseline
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Assessment method [4]
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Hematology parameters (PCI range): Eosinophils (<0.045 or >0.605 Giga cells per liter [GI/L]), Hematocrit (<0.297 or >0.506 ratio), Hemoglobin (<85 or >200 grams per liter [g/L]), Lymphocytes (<0.765 or >4.51GI/L), Mean Corpuscle Hemoglobin (MCH) (<24.3 or >38.5 picograms [PG]), Mean Corpuscle Hemoglobin Concentration (MCHC) (<256 or >432 g/L), Mean Corpuscle Volume (MCV) (<70 or >115 femtoliter [FL]), Monocytes (<0.18 or >1.21 GI/L), Platelet count (<104 or >480 GI/L), Red Cell Distribution Width (RDW) (<7.2 or >18%), Red Blood Cell (RBC) count (<2.88 or >6.12 trillion per liter [TI/L] for females and <3.52 or >6.96 TI/L for males) , Reticulocytes (<22.5 or >93.5 10^9/L), Total Absolute Neutrophil Count (ANC) (<1.62 or >8.8 GI/L), White Blood Cell (WBC) count (<3.04 or >12 GI/L) were analyzed. The data was presented as High and low, at any visit post-Baseline. Only parameters with observed abnormal values were presented.
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Timepoint [4]
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Up to Week 14
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Primary outcome [5]
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Number of Participants With Clinical Chemistry Data of PCI at Any Visit Post-Baseline
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Assessment method [5]
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Clinical chemistry parameters (PCI range): Alanine Amino Transferase (ALT) (>=3x upper limit normal [ULN] units per liter [U/L]), Albumin (<25.6 or >60 g/L), Alkaline Phosphatase (>=2x ULN U/L), Aspartate Amino Transferase (AST) (>=3x ULN U/L), Calcium (<2.0776 or >2.6112 millimoles per liter [mmol/L]), Carbon dioxide content/Bicarbonate (CO2/HCO3) (<19.6 or >32.64 mmol/L), Chloride (<93.1 or >110.16 mmol/L), Creatinine (<39.6 or >136.4 micromole per liter [µmol/L]) , Glucose (<3.51 or >6.05 mmol/L), Potassium (<3.43 or >5.406 mmol/L), Sodium (<132.3 or >148.92 mmol/L), Total Bilirubin (T. bilirubin) (>=1.5xULN µmol/L) , Total Protein (<50 or >95 g/L), Urea/Blood urea nitrogen (BUN) (<2.25 or >11.55 mmol/L) and Uric acid (<135 or >495 µmol/L) were analyzed. The data was presented as High and low, at any visit post-Baseline. Only parameters with observed abnormal values were presented.
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Timepoint [5]
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Up to Week 14
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Primary outcome [6]
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Number of Participants With Liver Function Test Elevations at Any Time Post-Baseline
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Assessment method [6]
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Liver function test parameters: Alanine aminotransferase (ALT), Total Bilirubin (T. Bilirubin), Aspartate aminotransferase (AST), Alkaline Phosphatase, Gamma glutamyl transferase (GGT) and Creatine Kinase were analyzed and presented as elevated test values at any time post-Baseline. The elevations were presented as >=2xULN, >=3xULN, >=5xULN, >=10xULN, and >=20xULN. n= number of participants with at least one non-missing result of the particular lab test post-Baseline.
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Timepoint [6]
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Up to Week 14
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Primary outcome [7]
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Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline
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Assessment method [7]
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A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT corrected (QTc) intervals. ECG findings were presented as Normal, Abnormal - Not clinically significant and Abnormal - Clinically significant at any time post-Baseline.
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Timepoint [7]
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Up to Week 14
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Primary outcome [8]
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Number of Participants With Vital Signs of PCI at Any Visit Post-Baseline
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Assessment method [8]
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Vital signs (PCI range): Systolic blood pressure (SBP) (<75 and >200 millimeter of mercury [mmHg]), Diastolic blood pressure (DBP) (<40 and >120 mmHg) and Heart rate (<30 and >200 beats per minute [bpm]) were analyzed and were presented at any visit post-Baseline. Participants with both Normal and Low values were counted once under their worst case (Low). Participants with both Normal and High values were counted once under their worst case (High). Participants with both High and Low values were counted under both categories. All heart rate values were within normal range, hence not presented.
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Timepoint [8]
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Up to Week 14
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Primary outcome [9]
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Mean High-sensitive C-Reactive Protein (hsCRP) Value at Week 12
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Assessment method [9]
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Analysis of hsCRP included all participants who provided data at Baseline and at least one post-Baseline measure. Statistical analyses was performed to compare hsCRP levels between study drug and placebo. Log transformed ratio to Baseline hsCRP was analyzed using repeated measures analysis of covariance (ANCOVA) including a term for treatment, adjusting for Baseline hsCRP as a covariate, and accounting for other covariates as appropriate to the study design.
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Timepoint [9]
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At Week 12
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Primary outcome [10]
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Mean Cardiac Troponin I (cTnI) Area Under Concentration-time Curve (AUC) Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)
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Assessment method [10]
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cTnI AUC was the average concentration of cTnI during hospital stay. Statistical analyses was performed to compare cTnI levels between study drug and placebo, via ANCOVA.
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Timepoint [10]
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At pre-dose and at 8, 16, 24, 32, 40, 48, 56, 64 and 72 hours
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Secondary outcome [1]
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Mean hsCRP Over Hospitalization Period and Through Week 14
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Assessment method [1]
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Analysis of hsCRP included all participants who provided data at Baseline and at least one post-Baseline measure. The sample had a collection window of +/- 8 hours. Statistical analyses was performed to compare hsCRP levels between study drug and placebo. Log transformed ratio to Baseline hsCRP was analyzed using ANCOVA including a term for treatment, adjusting for Baseline hsCRP as a covariate, and accounting for other covariates as appropriate to the study design.
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Timepoint [1]
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Up to Week 14
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Secondary outcome [2]
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Mean Interleukin-6 (IL-6) Value at 24 Hours Post-randomization and at Weeks 2 and 12
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Assessment method [2]
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Statistical analyses was performed to compare IL-6 levels between study drug and placebo. Log transformed ratio to Baseline IL-6 was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline IL-6 as a covariate, and accounting for other covariates as appropriate to the study design.
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Timepoint [2]
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24 hours post-randomization and at Weeks 2 and 12
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Secondary outcome [3]
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Mean Creatine Kinase (MB Isoenzyme) (CK-MB) AUC Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)
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Assessment method [3]
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Statistical analyses was performed to compare CK-MB levels between study drug and placebo. Log transformed ratio to Baseline CK-MB was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline CK-MB as a covariate, and accounting for other covariates as appropriate to the study design.
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Timepoint [3]
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At pre-dose and at hours 8, 16, 24, 32, 40, 48, 56, 64 and 72
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Secondary outcome [4]
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Peak cTnI Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)
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Assessment method [4]
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Statistical analyses was performed to compare cTnI levels between study drug and placebo. Log transformed ratio to Baseline cTnI was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline cTnI as a covariate, and accounting for other covariates as appropriate to the study design.
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Timepoint [4]
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Up to 72 hours
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Secondary outcome [5]
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Mean Brain Natriuretic Peptide (BNP) at Discharge and Week 12
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Assessment method [5]
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Statistical analyses was performed to compare BNP levels between study drug and placebo. Log transformed ratio to Baseline BNP was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline BNP as a covariate, and accounting for other covariates as appropriate to the study design.
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Timepoint [5]
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At discharge and Week 12
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Secondary outcome [6]
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Mean Infarct Size Prior to Discharge From Hospital (Approximately Day 3) and at Week 12
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Assessment method [6]
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Statistical analyses was performed to compare the infarct size (via MRI) at Week 12 via repeated measures ANOVA between study drug and placebo using Bayesian methods for inference. Myocardial infarct size was measured by delayed enhancement magnetic resonance imaging (MRI) as: Infarct size (% of left ventricular myocardium [% of LV]) for infarct 1. The infarct region 1 was the infarct region which the MRI interpretation process identified as the primary infarct region of the index hospitalization. Participants were included in the analyses, provided they have data for derivation of the measures of interest (MR infarct size). A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.
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Timepoint [6]
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Prior to discharge (visit 1) and at Week 12
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Secondary outcome [7]
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Mean Percent Left Ventricular Ejection Fraction (LVEF) at Week 12
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Assessment method [7]
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Statistical analyses of the treatment differences was performed to compare the LVEF (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.
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Timepoint [7]
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At Week 12
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Secondary outcome [8]
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Mean Left Ventricular End-diastolic Volume (LVEDV) and Left Ventricular End-systolic Volume (LVESV) at Week 12
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Assessment method [8]
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Statistical analyses of the treatment differences was performed to compare the LVEDV and LVESV (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.
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Timepoint [8]
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At Week 12
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Secondary outcome [9]
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Mean Left Ventricular Mass at Week 12
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Assessment method [9]
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Statistical analyses of the treatment differences was performed to compare the left ventricular mass (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo.Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.
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Timepoint [9]
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At Week 12
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Secondary outcome [10]
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Mean Regional Wall Motion Score Index at Week 12
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Assessment method [10]
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Wall motion score index is a semi-quantitative analysis of regional systolic function. Each segment is analyzed individually and scored on the basis of its motion and systolic thickening. This score is a 5-level score defines as: 1=normokinesis or hyperkinesis, 2=hypokinesi, 3=akinesis, 4=dyskinesis, 5=aneurysm. Wall motion score index is derived as a sum of all scores divided by the number of segments visualized. Larger score index indicates higher degree of abnormalities. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.
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Timepoint [10]
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At Week 12
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Secondary outcome [11]
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Mean Hyperenhancement Score Index at Week 12
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Assessment method [11]
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The myocardium was divided into 17 segments. A score ranging from 0 to 4 was visually attributed to each of the 17 segments according to the transmural extent of the hyperenhancement: score 0=0%, 1=>0-25%, 2=>25-50%, 3=>50-75% and 4=>75-100%. All these 17 scores were summed. The resulting summed score ranged in theory from 0 to 68 and was thereafter expressed as a percentage of the maximum possible score of 68, with higher percentages indicating hyper-enhancement in a greater percentage of the tissue in a greater number of segments. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. Statistical analysis was performed on LS mean value using repeated measures ANCOVA.
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Timepoint [11]
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At week 12
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Eligibility
Key inclusion criteria
- Subjects with a NSTEMI, defined as: symptoms (e.g. chest pain, dyspnea) consistent
with acute coronary syndrome, lasting at least 10 minutes, with most recent symptoms
occurring within the 24 hours prior to presentation, without persistent ST-segment
elevation on admission 12-lead ECG, and with Troponin (T or I) above the upper limit
of normal (ULN) for the local institution within 18 hours of presentation.
- Subject able to be randomized within 18 hours of presentation.
- Subjects to be managed with an early invasive strategy, with PCI likely to occur at
least 2 hours after the start of dosing [subjects who do not undergo PCI will not be
withdrawn from the study].
- Male or female subject who is 45 years of age or older.
- A female subject is eligible to participate if she is of: Non-childbearing potential
defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or
postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a
blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40
MlU/ml and estradiol less than 40 pg/ml (less than 140 pmol/L) is confirmatory), or
child-bearing potential and agrees to use one of the contraception methods listed in
the protocol for the duration of dosing and until the first follow-up visit
(approximately 2 weeks post last-dose).
- Negative urine or serum pregnancy test (in women of child-bearing potential only).
- Male subjects must agree to use one of the contraception methods listed in the
protocol. This criterion must be followed from the time of the first dose of study
medication until the first follow-up visit (approximately 2 weeks post last-dose).
- QTcB or QTcF greater than 530 msec.
- Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.
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Minimum age
45
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History of severe heart failure defined as NYHA class III or IV or those with known
severe LV dysfunction [ejection fraction less than 30%] regardless of symptomatic
status.
- Suspected aortic dissection.
- Severe aortic stenosis or other severe valvular disease.
- Current known life-threatening condition other than vascular disease (e.g. severe
chronic airways disease) that may prevent a subject from completing the study.
- Subjects with rheumatoid arthritis, connective tissue disorders and other conditions
known to be associated with active chronic or acute inflammation (e.g. inflammatory
bowel disease, osteomyelitis, pneumonia, etc.). Intermittent conditions treated with
short-term oral antibiotics (e.g. typical URI) or conditions that are not currently
exacerbated (e.g. gout with no current flair) may be included.
- History of myopathy or rhabdomyolysis.
- Current or chronic history of liver disease, known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Known to be Hepatitis B or Hepatitis C positive.
- Current or anticipated use of systemic steroids (oral or IV). Inhaled, intranasal and
topical steroids are allowed. A single prophylactic dose of systemic steroid is
allowed at time of PCI for subjects with contrast allergy.
- Current or anticipated use of BCRP substrates with a narrow therapeutic index (e.g.
daunorubicin, doxorubicin, topotecan, mitoxantrone).
- Previously diagnosed cancer that has not been in complete remission for at least 5
years. Localized carcinomas of the skin and carcinoma in situ of the cervix that have
been resected or ablated for cure are not exclusionary..
- Known alcohol or drug abuse within the past 6 months.
- Previous exposure to GW856553.
- Use of another investigational product within 30 days or 5 half-lives (whichever is
the longer) preceding the first dose of IP in the current study.
- Any other subject whom the Investigator deems unsuitable for the study (e.g., due to
either medical reasons, laboratory abnormalities, expected study medication
non-compliance).
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Previous MI or coronary artery bypass graft (CABG) surgery.
- History of kidney transplant or a history of contrast nephropathy.
- Contraindication to MRI scanning (as assessed by local MRI safety questionnaire) which
includes but is not limited to: intracranial aneurysm clips or other metallic objects;
history of intra-orbital metal fragments that have not been removed by an MD;
pacemakers and non-MR compatible heart valves; inner ear implants; history of
claustrophobia in MR.
- Allergy to MRI contrast enhancement agent (gadolinium).
- Estimated creatinine clearance by Cockcroft-Gault formula < 30 mL/min.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/10/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/03/2012
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Sample size
Target
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Accrual to date
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Final
526
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA
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Recruitment hospital [1]
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GSK Investigational Site - Kogarah
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Recruitment hospital [2]
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GSK Investigational Site - Liverpool
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Recruitment hospital [3]
0
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GSK Investigational Site - Brisbane
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Recruitment hospital [4]
0
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GSK Investigational Site - Bedford Park
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Recruitment hospital [5]
0
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GSK Investigational Site - Woodville South
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Recruitment hospital [6]
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GSK Investigational Site - Launceston
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Recruitment hospital [7]
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GSK Investigational Site - Fremantle
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Recruitment hospital [8]
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GSK Investigational Site - Perth
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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2170 - Liverpool
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Recruitment postcode(s) [3]
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4032 - Brisbane
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Recruitment postcode(s) [4]
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5042 - Bedford Park
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Recruitment postcode(s) [5]
0
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5011 - Woodville South
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Recruitment postcode(s) [6]
0
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7250 - Launceston
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Recruitment postcode(s) [7]
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6160 - Fremantle
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Recruitment postcode(s) [8]
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6000 - Perth
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alaska
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Georgia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Illinois
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Indiana
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Iowa
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Kentucky
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Minnesota
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Country [11]
0
0
United States of America
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State/province [11]
0
0
New York
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Country [12]
0
0
United States of America
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State/province [12]
0
0
North Carolina
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Ohio
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Pennsylvania
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Country [15]
0
0
United States of America
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State/province [15]
0
0
South Dakota
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Tennessee
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Country [17]
0
0
United States of America
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State/province [17]
0
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Texas
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Country [18]
0
0
Canada
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State/province [18]
0
0
Alberta
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Country [19]
0
0
Canada
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State/province [19]
0
0
Quebec
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Country [20]
0
0
Germany
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State/province [20]
0
0
Baden-Wuerttemberg
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Country [21]
0
0
Germany
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State/province [21]
0
0
Brandenburg
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Country [22]
0
0
Germany
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State/province [22]
0
0
Hessen
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Country [23]
0
0
Germany
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State/province [23]
0
0
Niedersachsen
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Country [24]
0
0
Germany
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State/province [24]
0
0
Nordrhein-Westfalen
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Pune
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Warszawa
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Alicante
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United Kingdom
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London
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United Kingdom
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Paddington, London
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Funding & Sponsors
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Commercial sector/Industry
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GlaxoSmithKline
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Summary
Brief summary
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study to
evaluate initial safety and efficacy of GW856553 in subjects with NSTEMI. Up to approximately
525 subjects will be randomized to meet the MRI recruitment target (90 subjects in substudy.)
All subjects will continue to receive the local standard of care for the duration of the
study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00910962
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GSK Clinical Trials
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GlaxoSmithKline
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00910962
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