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NCT00495885 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus
A Phase 3 study of Sleep Initiation and Maintenance Disorders, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 848
- Enrollment target
- 16
- Study locations
NCT00495885 is a Phase 3 study of Sleep Initiation and Maintenance Disorders that has completed, run by Sanofi. The registered enrollment target is 848 participants, above the 245-participant average among 19 other Sleep Initiation and Maintenance Disorders trials with a reported enrollment target (246% higher). The trial reports 16 study locations across 2 states.
The verdict
NCT00495885, a Phase 3 study of Sleep Initiation and Maintenance Disorders, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 848 participants
- Enrollment target
- 16
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG volinanserin (M100907)
Study Locations (16)
Other
- Sanofi-Aventis Administrative Office - São Paulo
- Sanofi-Aventis Administrative Office - Laval
- Sanofi-Aventis Administrative Office - Bogotá
- Sanofi-Aventis Administrative Office - Prague
- Sanofi-Aventis Administrative Office - Helsinki
- Sanofi-Aventis Administrative Office - Paris
- Sanofi-Aventis Administrative Office - Athens
- Sanofi-Aventis Administrative Office - Milan
- Sanofi-Aventis Administrative Office - Kuala Lumpur
- Sanofi-Aventis Administrative Office - Gouda
- Sanofi-Aventis Administrative Office - Moscow
- Sanofi-Aventis Administrative Office - Midrand
- Sanofi-Aventis Administrative Office - Geneva
- Sanofi-Aventis Administrative Office - Taipei
- Sanofi-Aventis Administrative Office - Istanbul
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 848 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00495885
The ClinicalTrials.gov registry entry for NCT00495885 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 848 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 245-participant average among 19 other Sleep Initiation and Maintenance Disorders trials with a reported enrollment target (246% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Sleep Initiation and Maintenance Disorders appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00495885 reports 16 study locations spanning 2 distinct geographic areas - top geographies include Other, New Jersey.
Frequently Asked Questions
What is clinical trial NCT00495885 about?
NCT00495885 is a clinical study titled "Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus". 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.
What is the current status of trial NCT00495885?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 848 participants. The study started on 2007-06. Estimated completion is 2008-10.
What conditions does trial NCT00495885 study?
This clinical trial studies the following conditions: Sleep Initiation and Maintenance Disorders.
What interventions are being tested in trial NCT00495885?
The interventions under investigation include: Placebo (DRUG), volinanserin (M100907) (DRUG).
Who is sponsoring clinical trial NCT00495885?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00495885 being conducted?
This trial has 16 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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