Safety of Ramelteon in Subjects With Mild to Moderate Obstructive Sleep Apnea
NCT00672061 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2012-02-28
Summary
The purpose of this study is to assess the safety of ramelteon, once daily (QD), in individuals with obstructive sleep apnea.
Conditions
- Sleep Apnea, Obstructive
Interventions
- DRUG
-
Ramelteon or Placebo
Ramelteon 16 mg, tablet, orally, once daily for Periods 1 or 2 and ramelteon placebo-matching tablets, orally, once daily for Periods 1 or 2.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
VP Clinical Science · Takeda
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 21 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-07-31
- Primary Completion
- 2003-12-31
- Completion
- 2003-12-31
Countries
- United States
Study Locations
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