Clinical Trial Details
| Trial ID: | L6488 |
| Source ID: | NCT00464061 |
| Associated Drug: | Volinanserin |
| Title: | Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus |
| Acronym: | SAMS |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | Sleep Initiation and Maintenance Disorders |
| Interventions: | DRUG: Volinanserin|DRUG: Placebo |
| Outcome Measures: | Primary: Efficacy: change from baseline for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO), at 3 months|Efficacy (sub-study): change from baseline for glycemic measure HbA1c, at 6 and 12 months | Secondary: Efficacy: change from baseline of the pr-WASO, at 6 and 12 months|Efficacy: change from baseline of "General Productivity" domain score of the Functional Outcomes of Sleep Questionnaire, at 3 months|Safety: adverse events and laboratory abnormalities, during 12 months of treatment |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 1847 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2007-04 |
| Completion Date: | 2009-03 |
| Results First Posted: | |
| Last Update Posted: | 2016-05-26 |
| Locations: | Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, 08807, United States|Sanofi-Aventis Administrative Office, Buenos Aires, Argentina|Sanofi-Aventis Administrative Office, Macquarie Park, Australia|Sanofi-Aventis Administrative Office, Vienna, Austria|Sanofi-Aventis Administrative Office, Diegem, Belgium|Sanofi-Aventis Administrative Office, Sao Paulo, Brazil|Sanofi-Aventis Administrative Office, Laval, Canada|Sanofi-Aventis Administrative Office, Santiago, Chile|Sanofi-Aventis Administrative Office, Santafe de Bogota, Colombia|Sanofi-Aventis Administrative Office, Praha, Czech Republic|Sanofi-Aventis Administrative Office, Berlin, Germany|Anofi-Aventis Administrative Office, Causeway Bay, Hong Kong|Sanofi-Aventis Administrative Office, Mumbai, India|Sanofi-Aventis Administrative Office, Milano, Italy|Sanofi-Aventis Administrative Office, Kuala Lumpur, Malaysia|Sanofi-Aventis Administrative Office, Mexico, Mexico|Sanofi-Aventis Administrative Office, Moscow, Russian Federation|Sanofi-Aventis Administrative Office, Singapore, Singapore|Sanofi-Aventis Administrative Office, Midrand, South Africa|Sanofi-Aventis Administrative Office, Barcelona, Spain|Sanofi-Aventis Administrative Office, Istanbul, Turkey|Sanofi-Aventis Administrative Office, Guildford, Surrey, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT00464061 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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