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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00564226 |
The primary objective of this study is to evaluate the efficacy of SSR240600C in women with overactive bladder compared to placebo using tolterodine as a study calibrator.
Condition | Intervention | Phase |
---|---|---|
Overactive Bladder |
Drug: SSR240600C Drug: tolterodine Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Placebo Controlled Randomized, 12-Week, Dose-Ranging, Double-Blind Study Versus Placebo Using Tolterodine as a Study Calibrator, to Evaluate Efficacy and Safety of SSR240600C in Women With Overactive Bladder Including Urge Urinary Incontinence |
Estimated Enrollment: | 800 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
dose level 1
|
Drug: SSR240600C
oral administration
|
2: Experimental
dose level 2
|
Drug: SSR240600C
oral administration
|
3: Experimental
dose level 3
|
Drug: SSR240600C
oral administration
|
4: Active Comparator |
Drug: tolterodine
oral administration
|
5: Placebo Comparator |
Drug: placebo
oral administration
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
United States, New Jersey | |
Sanofi-Aventis Aministrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Canada, Quebec | |
Sanofi-Aventis Administrative Office | |
Laval, Quebec, Canada | |
Czech Republic | |
Sanofi-Aventis Administrative Office | |
Praha, Czech Republic | |
France | |
Sanofi-Aventis Administrative Office | |
Paris, France | |
Germany | |
Sanofi-Aventis Administrative Office | |
Berlin, Germany | |
Netherlands | |
Sanofi-Aventis Administrative Office | |
Gouda, Netherlands | |
Portugal | |
Sanofi-Aventis Administrative Office | |
Porto Salvo, Portugal |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | DRI6271, EudraCT 2007-004126-24 |
Study First Received: | November 26, 2007 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00564226 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Netherlands: Medicines Evaluation Board (MEB) |
urge urinary incontinence |
Signs and Symptoms Urinary Bladder, Overactive Cystocele Urologic Diseases Urination Disorders |
Urinary Bladder Diseases Urinary Incontinence Urinary Incontinence, Urge Tolterodine |
Muscarinic Antagonists Urological Manifestations Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Cholinergic Antagonists Physiological Effects of Drugs Cholinergic Agents Pharmacologic Actions |