Trial Profile
Efficacy and Safety of 3-Week Fixed-Dose Asenapine Treatment in Pediatric Acute Manic or Mixed Episodes Associated With Bipolar I Disorder (Protocol No. P06107).
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 05 May 2022
Price :
$35
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At a glance
- Drugs Asenapine (Primary)
- Indications Bipolar I disorders
- Focus Therapeutic Use
- Acronyms Gemini-BP3
- Sponsors Merck Sharp & Dohme
- 01 Dec 2015 Results published in the Journal of the American Academy of Child and Adolescent Psychiatry
- 13 Mar 2015 According to an Actavis media release, based on the results of this trial US FDA has approved its sNDA for asenapine [SAPHRIS] as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients.
- 02 Oct 2013 The status of the extension study has changed from recruiting to active, no longer recruiting, according to the ClinicalTrials.gov record.