CLINICAL TRIALS PROFILE FOR ASENAPINE
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All Clinical Trials for Asenapine
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00143182 ↗ | 9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED) | Completed | Pfizer | Phase 3 | 2005-01-07 | Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed the 3 week trial (A7601004 or A7501005) continued on the same treatment that they received in the short term study: asenapine or olanzapine (a medication already approved for the treatment of bipolar mania) for 9 additional weeks. The short term studies (A7501004 and A7501005) were not unblinded until the 9 week extension study was unblinded. Patients treated with placebo in the 3 week short term study were crossed over and treated with Asenapine in the 9 week extension study. Patients who complete the 9 week extension study were eligible to continue in another extension (A7501007) study for an additional 40 weeks. |
| NCT00143182 ↗ | 9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | 2005-01-07 | Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed the 3 week trial (A7601004 or A7501005) continued on the same treatment that they received in the short term study: asenapine or olanzapine (a medication already approved for the treatment of bipolar mania) for 9 additional weeks. The short term studies (A7501004 and A7501005) were not unblinded until the 9 week extension study was unblinded. Patients treated with placebo in the 3 week short term study were crossed over and treated with Asenapine in the 9 week extension study. Patients who complete the 9 week extension study were eligible to continue in another extension (A7501007) study for an additional 40 weeks. |
| NCT00145470 ↗ | 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) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | 2005-06-02 | This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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