Trials / Terminated
TerminatedNCT00464061
Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus
Efficacy and Safety of 2mg/Day of M100907 on Sleep Maintenance Insomnia With a Sub-study of the Effect of M100907 on Stable Type II Diabetes Mellitus: a One Year, Multi-center, Randomized, Double-blind, Placebo-controlled Study
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,847 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia. The objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Volinanserin | oral administration |
| DRUG | Placebo | oral administration |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2009-03-01
- Completion
- 2009-03-01
- First posted
- 2007-04-20
- Last updated
- 2016-05-26
Locations
22 sites across 22 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Germany, Hong Kong, India, Italy, Malaysia, Mexico, Russia, Singapore, South Africa, Spain, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT00464061. Inclusion in this directory is not an endorsement.