Clinical trial
12 Week Study of the Safety/Efficacy of Asenapine When Added to…
NCT00145470 · Organon and Co, Industry · Completed
Key facts
| NCT number | NCT00145470 |
|---|---|
| Title | 12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017) |
| Official title | A Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial Evaluating the Safety and Efficacy of Asenapine in Subjects 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 | 326 |
| Start date | Jun 2, 2005 |
| Primary completion | Feb 28, 2007 |
| Completion | Mar 22, 2007 |
| First posted | Sep 5, 2005 |
| Last update posted | May 21, 2024 |
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: