Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00044915




Registration number
NCT00044915
Ethics application status
Date submitted
6/09/2002
Date registered
9/09/2002
Date last updated
12/06/2009

Titles & IDs
Public title
Repinotan in Patients With Acute Ischemic Stroke
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic / Pharmacodynamic Effects of a Targeted Exposure of Intravenous Repinotan in Patients With Acute Ischemic Stroke
Secondary ID [1] 0 0
100282
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Acute Ischemic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Repinotan HCl (BAYX3702)
Treatment: Drugs - Placebo

Active comparator: Arm 1 -

Placebo comparator: Arm 2 -


Treatment: Drugs: Repinotan HCl (BAYX3702)
All patients receive 1.25 mg of repinotan

Treatment: Drugs: Placebo
All patients receive 1.25 mg of placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Acute ischemic stroke of hemispheric localization (exclude brainstem and cerebellum), of suspected thromboembolic origin.
* Males or females aged 18 years or over.
* National Institute of Health Stroke Scale (NIH-SS) total score 8 to 23 with a motor deficit >/= 2 (for either one arm or leg) and level of consciousness < 2 and at least one of the following: Visual field deficit, neglect, or aphasia. If a patient receives t-PA, NIH-SS must be performed prior to receiving the study drug but after infusion of t-PA is initiated.
* Signed informed consent from patient or legally authorized representative
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* CT scan evidence of:
* Clearly defined areas of hypodensity indicating infarction of >1/3 of the MCA territory or evidence of significant mass effect with shift of midline or major areas of sulcal effacement associated with loss of cortical definition (grey-white distinction). Minor early CT changes are common in MCA strokes and patients with early or subtle changes are eligible.
* A primary intra-cerebral haemorrhage or any finding not consistent with an acute ischemic stroke as the cause of presenting symptoms.
* Clinical evidence of acute stroke due to lacunar infarct (pure motor hemiplegia; pure sensory deficit, ataxia/clumsy hand syndromes)
* Neurological (other than the presenting stroke) or psychiatric conditions that may affect the patient's functional status and/or that may interfere with the patient's assessment
* Clinically relevant pre-existing neurological deficit (Historical Rankin score >/= 2 regardless of cause)
* Generalized seizures having developed since the onset of stroke symptoms
* Systolic blood pressure > 210 or < 110 mmHg (confirmed by up to three readings prior to randomization)
* Diastolic blood pressure > 110 or < 60 mmHg (confirmed by up to three readings prior to randomization)
* Myocardial infarction within 3 months, unstable angina within 3-5 days prior to starting infusion, unstable supra-ventricular and/or ventricular arrhythmia, severe conduction defect (AV block grades 2 and 3), complete left or right Bundle Branch Block, bradycardia (heart rate [HR] less than 50 bpm), uncompensated heart failure
* History of myocarditis, cardiomyopathy or aortic stenosis
* Patients known to have prolonged QTc intervals (inherited and sporadic syndromes of QTc prolongation or QTc interval > 450 msec males and 470 msec females on baseline ECG) or using Class IA or Class III antiarrhythmic drugs (e.g., quinidine, procainamide, amiodarone, sotalol)
* Any patients that require initiation of new digoxin therapy are excluded. Patients already on digoxin therapy (for at least 1 month stable dose) at time of enrollment will be allowed in the study.
* Electrolyte imbalance at baseline. Should the results not be available before starting the study drug infusion, the patients will be allowed in the study providing that the corrective therapy of any abnormal electrolyte results is implemented immediately upon availability of the laboratory report.
* Any conditions predisposing to electrolyte imbalances (e.g., chronic vomiting, anorexia nervosa, bulimia nervosa) will also be excluded at baseline.
* Participation in a research protocol for investigation of a pharmaceutical agent or innovative invasive procedure (including intra-arterial t-PA) within the past 30 days
* Previously in the BRAIN-Study or treated with repinotan
* Life expectancy of less than 6 months due to comorbid conditions
* Any other known clinically significant medical disorder (e.g., cardiovascular, gastrointestinal, hepatic, renal, endocrine, major uncompensated metabolic disturbances, respiratory, immunological, hematological or bleeding disorder, cancer, AIDS)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2004
Sample size
Target
Accrual to date
Final
782
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
- Gosford
Recruitment hospital [2] 0 0
- New Lambton Heights
Recruitment hospital [3] 0 0
- Southport
Recruitment hospital [4] 0 0
- Hobart
Recruitment hospital [5] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3011 - Melbourne
Recruitment postcode(s) [6] 0 0
3052 - Melbourne
Recruitment postcode(s) [7] 0 0
3084 - Melbourne
Recruitment postcode(s) [8] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Hawaii
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Montana
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Austria
State/province [19] 0 0
Niederösterreich
Country [20] 0 0
Austria
State/province [20] 0 0
Oberösterreich
Country [21] 0 0
Austria
State/province [21] 0 0
Wien
Country [22] 0 0
Belgium
State/province [22] 0 0
Bornem
Country [23] 0 0
Belgium
State/province [23] 0 0
Bruxelles - Brussel
Country [24] 0 0
Canada
State/province [24] 0 0
Alberta
Country [25] 0 0
Canada
State/province [25] 0 0
British Columbia
Country [26] 0 0
Canada
State/province [26] 0 0
Manitoba
Country [27] 0 0
Canada
State/province [27] 0 0
New Brunswick
Country [28] 0 0
Canada
State/province [28] 0 0
Nova Scotia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Canada
State/province [31] 0 0
Saskatchewan
Country [32] 0 0
Finland
State/province [32] 0 0
Helsinki
Country [33] 0 0
Finland
State/province [33] 0 0
Kuopio
Country [34] 0 0
Finland
State/province [34] 0 0
Lahti
Country [35] 0 0
Finland
State/province [35] 0 0
Mikkeli
Country [36] 0 0
France
State/province [36] 0 0
Bordeaux
Country [37] 0 0
France
State/province [37] 0 0
Nice
Country [38] 0 0
Germany
State/province [38] 0 0
Baden-Württemberg
Country [39] 0 0
Germany
State/province [39] 0 0
Bayern
Country [40] 0 0
Germany
State/province [40] 0 0
Hessen
Country [41] 0 0
Germany
State/province [41] 0 0
Mecklenburg-Vorpommern
Country [42] 0 0
Germany
State/province [42] 0 0
Nordrhein-Westfalen
Country [43] 0 0
Germany
State/province [43] 0 0
Rheinland-Pfalz
Country [44] 0 0
Germany
State/province [44] 0 0
Sachsen-Anhalt
Country [45] 0 0
Germany
State/province [45] 0 0
Sachsen
Country [46] 0 0
Germany
State/province [46] 0 0
Berlin
Country [47] 0 0
Hungary
State/province [47] 0 0
Miskolc
Country [48] 0 0
Israel
State/province [48] 0 0
Isarel
Country [49] 0 0
Israel
State/province [49] 0 0
Ashkelon
Country [50] 0 0
Israel
State/province [50] 0 0
Haifa
Country [51] 0 0
Israel
State/province [51] 0 0
Holon
Country [52] 0 0
Israel
State/province [52] 0 0
Nahariya
Country [53] 0 0
Israel
State/province [53] 0 0
Tel Aviv
Country [54] 0 0
Israel
State/province [54] 0 0
Tel Hashomer
Country [55] 0 0
Italy
State/province [55] 0 0
Como
Country [56] 0 0
Italy
State/province [56] 0 0
L'Aquila
Country [57] 0 0
Italy
State/province [57] 0 0
Milano
Country [58] 0 0
Italy
State/province [58] 0 0
Pavia
Country [59] 0 0
Italy
State/province [59] 0 0
Perugia
Country [60] 0 0
Italy
State/province [60] 0 0
Reggio Emilia
Country [61] 0 0
Italy
State/province [61] 0 0
Roma
Country [62] 0 0
Italy
State/province [62] 0 0
Verona
Country [63] 0 0
Italy
State/province [63] 0 0
Vibo Valentia
Country [64] 0 0
Italy
State/province [64] 0 0
Vicenza
Country [65] 0 0
Netherlands
State/province [65] 0 0
Groningen
Country [66] 0 0
Netherlands
State/province [66] 0 0
Nijmegen
Country [67] 0 0
Spain
State/province [67] 0 0
A Coruña
Country [68] 0 0
Spain
State/province [68] 0 0
Barcelona
Country [69] 0 0
Spain
State/province [69] 0 0
Madrid
Country [70] 0 0
Spain
State/province [70] 0 0
Valencia
Country [71] 0 0
Spain
State/province [71] 0 0
Zaragoza
Country [72] 0 0
Sweden
State/province [72] 0 0
Stockholm
Country [73] 0 0
Sweden
State/province [73] 0 0
Umeå
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Leicestershire
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Strathclyde
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Tayside

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00044915