Clinical trial
40 Week Trial to Study the Safety of Asenapine When Added to Lithium or…
NCT00145509 · Organon and Co, Industry · Completed
Key facts
| NCT number | NCT00145509 |
|---|---|
| Title | 40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786) |
| Official title | A Phase 3, Placebo-Controlled, Double-Blinded Continuation Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Completing a 12-week Lead-in Trial and Continuing Lithium or Valproic Acid/Divalproex Sodium for the Treatment of an Acute Manic or Mixed Episode |
| Lead sponsor | Organon and Co, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Bipolar Disorder |
| Intervention type | Drug |
| Interventions | Asenapine, Placebo |
| Enrollment | 77 |
| Start date | Aug 1, 2005 |
| Primary completion | Dec 1, 2007 |
| Completion | Dec 1, 2007 |
| First posted | Sep 5, 2005 |
| Last update posted | Feb 8, 2022 |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: