Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA)
NCT01620554 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2012-06-15
Summary
Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range).
Conditions
- Obstructive Sleep Apnoea
- Excessive Daytime Sleepiness
Interventions
- DRUG
-
BF2.649
1 capsule per week during 2 weeks
- DRUG
-
BF2.649
1 capsule per week during 2 weeks
- DRUG
-
BF2.649
1 capsule per week during 2 weeks
- DRUG
-
BF2.649
1 capsule per week during 2 weeks
- DRUG
-
1 capsule per week during 2 weeks
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Evelyne De Paillette, MD · Bioprojet
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-10-31
- Primary Completion
- 2011-12-31
- Completion
- 2011-12-31
Countries
- France
Study Locations
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