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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00614250 |
The primary objective of this study is to assess the activity of 4 escalating doses of AVE0657 in comparison to placebo in patients with Obstructive Sleep Apnea Hypopnea Syndrome.
Condition | Intervention | Phase |
---|---|---|
Sleep Apnea, Obstructive |
Drug: AVE0657 Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind, Randomized, Placebo-Controlled, Study of the Safety and Activity of Four Escalating Single Doses of AVE0657 in Patients Suffering From Obstructive Sleep Apnea Hypopnea Syndrome |
Estimated Enrollment: | 36 |
Study Start Date: | January 2008 |
Study Completion Date: | January 2009 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Dose Level 1: Experimental |
Drug: AVE0657
capsules once a day at bedtime
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Dose Level 2: Experimental |
Drug: AVE0657
capsules once a day at bedtime
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Dose Level 3: Experimental |
Drug: AVE0657
capsules once a day at bedtime
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Dose Level 4: Experimental |
Drug: AVE0657
capsules once a day at bedtime
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Placebo: Placebo Comparator
12 subjects: 3 subjects per dose level
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Drug: placebo
capsules once a day at bedtime
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
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.
France | |
Sanofi- Aventis Administrative Office | |
Paris, France | |
Germany | |
Sanofi-Aventis Administrative Office | |
Berlin, Germany | |
Spain | |
Sanofi-Aventis Administrative Office | |
Barcelona, Spain |
Principal Investigator: | Patrick LEVY, Professor | Hôpital Michallon - Grenoble - France |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | ACT6796, EudraCT 2007-002174-58 |
Study First Received: | January 31, 2008 |
Last Updated: | February 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00614250 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Spain: Ethics Committee |
Obstructive sleep apnea |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Nervous System Diseases Respiration Disorders |
Sleep Apnea, Obstructive Sleep Disorders Dyssomnias Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |