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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/NCT00490568
Registration number
NCT00490568
Ethics application status
Date submitted
21/06/2007
Date registered
22/06/2007
Date last updated
13/11/2017
Titles & IDs
Public title
Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
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Scientific title
An Open-label Extension to Study AVA102670 and AVA102672, to Assess the Long-term Safety and Efficacy of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy on Cognition in Subjects With Mild to Moderate Alzheimer's Disease.
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Secondary ID [1]
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AVA102675
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
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0
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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0
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rosiglitazone XR
Experimental: Rosiglitazone XR - Investigational drug
Treatment: Drugs: Rosiglitazone XR
Experimental drug
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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 Severity of AEs
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Assessment method [1]
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An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of the AE'S was categorized as mild, moderate and severe. Number of participants reporting AEs during the on treatment phase of the study.
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Timepoint [1]
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Up to 76 Weeks
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Secondary outcome [1]
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Number Participants With Serious Adverse Events (SAEs) and Deaths
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Assessment method [1]
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A SAE is defined as any untoward medical occurrence that, at any dose results in death, is a life-threatening condition, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or a congenital anomaly or birth defect. Number of participants with SAEs and deaths were reported for treatment duration of the study.
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Timepoint [1]
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Up to 76 Weeks
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Secondary outcome [2]
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Number of Participants With Adverse Event of Oedema
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Assessment method [2]
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Oedema was considered as adverse event of special interest (AESI). The process for AESI selection was based on RSG's pharmacologic class and relevant AEs potentially associated with RSG. The number of participants and their percentage for the adverse event of the various types of oedema were reported.
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Timepoint [2]
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Up to 76 Weeks
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Secondary outcome [3]
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Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
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Assessment method [3]
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Vital signs SBP and DBP were measured at each visit. All measurements were made on the participant non-dominant arm supported at heart level, using the same cuff size and same equipment. Blood pressure was measured once, after the participant sat quietly for at least 5 minutes. DBP was measured at the disappearance of Korotkoff sounds (Phase V). If the participant was a smoker or used tobacco products, a period of 30 minutes without tobacco was allowed before taking these measurements. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the blood pressure value recorded at specified visit minus the Baseline value.
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Timepoint [3]
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Up to 70 Weeks (including follow up)
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Secondary outcome [4]
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Change From Baseline in Vital Sign Heart Rate (HR)
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Assessment method [4]
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Vital sign HR was measured at each visit. HR was measured once, after the participant sat quietly for at least 5 minutes. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the HR at specified visit minus the Baseline value.
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Timepoint [4]
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Up to 70 Weeks (including follow up)
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Secondary outcome [5]
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Change From Baseline in Vital Sign Body Weight (BW)
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Assessment method [5]
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BW was measured at all visits, without shoes and wearing light clothing. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the body weight at specified visit minus the Baseline value.
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Timepoint [5]
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Up to 70 Weeks (including follow up)
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Secondary outcome [6]
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Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides
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Assessment method [6]
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The clinical chemistry data included non-fasting measures of lipid metabolism (TC,HDL,LDL,triglycerides). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the lipids (TC,HDL,LDL,triglycerides) value recorded at specified visit minus the Baseline value.
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Timepoint [6]
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Up to 82 Weeks (including follow up)
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Secondary outcome [7]
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Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC)
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Assessment method [7]
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The frequency of participant vital sign sitting blood pressure was obtained to check if the values lie outside of a pre-determined reference range (RR) for SBP 90-140 mmHg, DBP 50-90 mmHg or have a change from Baseline of PCC for SBP increase from Baseline (IFB) >=40, decrease from Baseline (DFB) >= 30 for and for DBP (IFB) >= 30 ,DFB >= 20. The number of participants with values of PCC at any time on treatment (ATOT) and follow up were reported.
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Timepoint [7]
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0
Up to 70 Weeks (including follow up)
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Secondary outcome [8]
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Number of Participants With HR Values of PCC ATOT
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Assessment method [8]
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HR was measured once, after the participant sat quietly for at least 5 minutes. The frequency of participant vital sign heart rate was obtained to check if the values lie outside of a pre-determined reference range (RR) 50-100 bpm or have a change from Baseline of PCC IFB >=30 and DFB >=30. The number of participants with values of PCC including follow up were reported.
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Timepoint [8]
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Up to 70 Weeks (including follow up)
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Secondary outcome [9]
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Number of Participants With BW Values of PCC ATOT
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Assessment method [9]
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The frequency of participant vital sign weight was obtained to check if the values have CFB of PCC IFB >=7 percent. With the exception of Week 4, when participants were first titrated to the 8mg RSG XR dose, at every time point in the study where weight was measured the percentage of participants experienced an increase in BW of PCC was approximately 2 times greater than the percentage of participants experiencing an decrease in BW of PCC DFB >=7 percent. The number of participants with values of PCC including follow up were reported.
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Timepoint [9]
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Up to 70 Weeks (including follow up)
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Secondary outcome [10]
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Number of Participants With Hematology Parameters of PCC ATOT
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Assessment method [10]
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The hematology data included eosinophils, haematocrit, haemoglobin, lymphocytes, mean corpuscular haemoglobin (MCH), mean corpuscular volume (MCV), monocytes, platelet count, red cell distribution width (RDW), red blood cell (RBC) count, segmented neutrophils (SN), total neutrophils (TN), white blood cell (WBC) count. The number of participants with values of PCC (defined as high and low) ATOT were reported.
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Timepoint [10]
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Up to Week 82 (including follow up)
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Secondary outcome [11]
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Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT
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Assessment method [11]
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The clinical chemistry data included alanine amino transferase (ALT), albumin, aldolase, asparatate amino transferase (AST), BUN/creatinine ratio, carbon dioxide(CO2) content, chloride, cholesterol, creatinine kinase (CK), creatinine, direct bilirubin (DB), gamma glutamyl transferase (GGT), glucose, glycosylated Hemoglobin (HbA1C), HDL, LDL, lactate dehydrogenase (LD), magnesium, potassium, sodium, total bilirubin (TB), triglycerides, troponin I, urea. The number of participants with values of PCC (defined as high and low) ATOT were reported.
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Timepoint [11]
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Up to Week 82 (including follow up)
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Secondary outcome [12]
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Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score as a Function of Apolipoprotein E (APOE) e4 Status.
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Assessment method [12]
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The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores ranged from 0 to 70 with higher scores indicating greater dysfunction. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.
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Timepoint [12]
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Baseline (Week 0) and Week 24, 52
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Secondary outcome [13]
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Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score as a Function of APOE e4 Status.
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Assessment method [13]
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The CDR-SB is a validated clinical assessment of global function in par. with Alzheimer's disease (AD). Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or box scores, were added together to give the CDR-Sum of Boxes which ranged from 0 to 18 (severe impairment). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.
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Timepoint [13]
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Baseline (Week 0) and Week 24, 52
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Secondary outcome [14]
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Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE e4 Status.
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Assessment method [14]
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The MMSE consisted of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores ranged from 0 to 30, with lower scores indicating greater cognitive impairment. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.
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Timepoint [14]
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Baseline (Week 0) and Week 24, 52
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Secondary outcome [15]
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Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE e4 Status.
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Assessment method [15]
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DAD, assessed the ability of a participant to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assesses a participant's ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. The percentage score was calculated as (DAD total score/total number of applicable items) * 100. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.
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Timepoint [15]
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Baseline (Week 0) and Week 24, 52
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Secondary outcome [16]
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Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE e4 Status.
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Assessment method [16]
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12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, appetite, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions=participant has problems with a particular sub-domain of behavior, the caregiver asked all the questions about that domain, rating the frequency (1=occasionally to 4=very frequently) on a 4-point scale, their severity (1=Mild to 3=Severe) on a 3-point scale, and the distress on a 5-point scale. Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.
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Timepoint [16]
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Baseline (Week 0) and Week 24, 52
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Eligibility
Key inclusion criteria
Inclusion criteria:
- Successful completion of AVA102670 or AVA102672 without safety or tolerability issues.
Regular caregiver.
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Minimum age
51
Years
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Maximum age
91
Years
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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
Exclusion criteria:
- Congestive Heart Failure (NYHA 1-4), clinically significant peripheral edema, other
neurological conditions that might disqualify participation. SAE, clinically
significant laboratory abnormality or significant cardiovascular event during prior
study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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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
8/08/2007
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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
1/06/2009
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Sample size
Target
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Accrual to date
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Final
1461
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - Hornsby
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Recruitment hospital [2]
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GSK Investigational Site - Randwick
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Recruitment hospital [3]
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GSK Investigational Site - Auchenflower
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Recruitment hospital [4]
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GSK Investigational Site - Chermside
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Recruitment hospital [5]
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GSK Investigational Site - Kippa Ring
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Recruitment hospital [6]
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GSK Investigational Site - Woodville
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Recruitment hospital [7]
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GSK Investigational Site - Cheltenham
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Recruitment hospital [8]
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GSK Investigational Site - Heidelberg Heights
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Recruitment hospital [9]
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GSK Investigational Site - Kew
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Recruitment hospital [10]
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GSK Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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2077 - Hornsby
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Recruitment postcode(s) [2]
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2031 - Randwick
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Recruitment postcode(s) [3]
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4066 - Auchenflower
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Recruitment postcode(s) [4]
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4032 - Chermside
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Recruitment postcode(s) [5]
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4021 - Kippa Ring
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Recruitment postcode(s) [6]
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5011 - Woodville
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Recruitment postcode(s) [7]
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3192 - Cheltenham
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Recruitment postcode(s) [8]
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3084 - Heidelberg Heights
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Recruitment postcode(s) [9]
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3101 - Kew
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Recruitment postcode(s) [10]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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Arkansas
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California
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Connecticut
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Florida
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Indiana
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United States of America
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Maryland
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Massachusetts
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Minnesota
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Rhode Island
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Texas
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Utah
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Vermont
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Córdova
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Argentina
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Mendoza
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Argentina
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Ciudad Autonoma de Buenos Aires
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Austria
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Hall in Tirol
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Vienna
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Kortrijk
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Leuven
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Woluwe-Saint-Lambert
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Bulgaria
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Sofia
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Varna
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New Brunswick
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Nova Scotia
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Ontario
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Canada
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Prince Edward Island
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Canada
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Saskatchewan
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Québec
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Chile
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Región Metro De Santiago
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Chile
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Valparaíso
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Czechia
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Olomouc
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Czechia
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Ostrava
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Czechia
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Praha 10
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Czechia
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Czechia
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Czechia
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Czechia
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Praha 8
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Czechia
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Trutnov
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Finland
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Helsinki
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Finland
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Kuopio
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Caen
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France
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Dijon
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Ivry
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France
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Lille
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France
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Limoges
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France
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Luynes
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0
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France
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Lyon
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France
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Marseille
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0
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France
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0
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Metz
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0
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France
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Nantes
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0
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France
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Nice
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France
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Paris
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France
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Pau
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0
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France
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Rodez
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France
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Saint Ouen la Rouerie
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France
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Saint-Etienne
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France
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State/province [69]
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Sautron
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Germany
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Shatin
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Valencia
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Sundsvall
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Umeå
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United Kingdom
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Lancashire
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Bradford
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Liverpool
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United Kingdom
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West of Scotland Science Park, Glasgow
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Funding & Sponsors
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Commercial sector/Industry
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Name
GlaxoSmithKline
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Ethics approval
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Summary
Brief summary
This is a Phase III, multicenter, open-label extension, single-group study in male and female
outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either
AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg
once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to
their existing dose of acetylcholinesterase inhibitor. Subject participation will last until
one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend
a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this
study is to evaluate the long-term safety and tolerability of RSG XR in subjects with
mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective
of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive
function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele
status.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00490568
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Trial related presentations / publications
Harrington C, Sawchak S, Chiang C, Davies J, Donovan C, Saunders AM, Irizarry M, Jeter B, Zvartau-Hind M, van Dyck CH, Gold M. Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: two phase 3 studies. Curr Alzheimer Res. 2011 Aug;8(5):592-606. doi: 10.2174/156720511796391935.
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Public notes
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Contacts
Principal investigator
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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/NCT00490568
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