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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00044915 |
Purpose
The purpose of this trial is to evaluate Repinotan HCl in patients with acute ischemic stroke. At study entry patients will be randomized to Repinotan HCl or placebo in a 1:1 ratio. The total treatment period wil be 72 hours.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke Acute Ischemic Stroke |
Drug: Repinotan HCl (BAYX3702) Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official 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 |
| Enrollment: | 782 |
| Study Start Date: | December 2000 |
| Study Completion Date: | September 2004 |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Active Comparator |
Drug: Repinotan HCl (BAYX3702)
All patients receive 1.25 mg of repinotan
|
| Arm 2: Placebo Comparator |
Drug: Placebo
All patients receive 1.25 mg of placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 119 Study Locations| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
| Study ID Numbers: | 100282 |
| Study First Received: | September 6, 2002 |
| Last Updated: | June 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00044915 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Acute Ischemic Stroke Without Hemorrhage |
|
Pathologic Processes Cerebral Infarction Nervous System Diseases Stroke Vascular Diseases Brain Ischemia |
Central Nervous System Diseases Cardiovascular Diseases Brain Infarction Ischemia Brain Diseases Cerebrovascular Disorders |