Clinical Trial Details
| Trial ID: | L5629 |
| Source ID: | NCT00495885 |
| Associated Drug: | Volinanserin (M100907) |
| Title: | Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus |
| Acronym: | SAMS12 |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Sleep Initiation and Maintenance Disorders |
| Interventions: | DRUG: volinanserin (M100907)|DRUG: Placebo |
| Outcome Measures: | Primary: change from baseline to 12 weeks for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO), 12 weeks | Secondary: Change from baseline to 12-week of "General Productivity" domain from Functional Outcomes of Sleep Questionnaire (FOSQ)., 12 weeks |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 848 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2007-06 |
| Completion Date: | 2008-10 |
| Results First Posted: | |
| Last Update Posted: | 2016-05-26 |
| Locations: | Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, 08807, United States|Sanofi-Aventis Administrative Office, Sao Paulo, Brazil|Sanofi-Aventis Administrative Office, Laval, Canada|Sanofi-Aventis Administrative Office, Santafe de Bogota, Colombia|Sanofi-Aventis Administrative Office, Praha, Czech Republic|Sanofi-Aventis Administrative Office, Helsinki, Finland|Sanofi-Aventis Administrative Office, Paris, France|Sanofi-Aventis Administrative Office, Athens, Greece|Sanofi-Aventis Administrative Office, Milan, Italy|Sanofi-Aventis Administrative Office, Kuala Lumpur, Malaysia|Sanofi-Aventis Administrative Office, Gouda, Netherlands|Sanofi-Aventis Administrative Office, Moscow, Russian Federation|Sanofi-Aventis Administrative Office, Midrand, South Africa|Sanofi-Aventis Administrative Office, Geneva, Switzerland|Sanofi-Aventis Administrative Office, Taipei, Taiwan|Sanofi-Aventis Administrative Office, Istanbul, Turkey |
| URL: | https://clinicaltrials.gov/show/NCT00495885 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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