Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692AM2)
This study is currently recruiting participants.
Verified May 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01395992
First received: July 14, 2011
Last updated: May 22, 2013
Last verified: May 2013
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Purpose
Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for eligibility for this 26-week extension study in which they will continue treatment. The primary purpose of this trial is to evaluate the long-term safety of asenapine.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar I Disorder |
Drug: asenapine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine in Subjects Diagnosed With Bipolar 1 Disorder Who Completed Protocol P05691 (Formerly 041044) (Phase3B, Protocol P05692 [Formerly 041045]) |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Number of participants experiencing clinical and laboratory adverse events (AEs) [ Time Frame: Baseline up to 212 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 230 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Asenapine 5 mg
Participants who were randomized to asenapine 5 mg twice per day (BID) during the P05691 study will be assigned to receive asenapine 5 mg BID on this extension study. Participant who were randomized to placebo during the P05691 study will be assigned to receive asenapine 5 mg BID on this extension trial.
|
Drug: asenapine
asenapine 5 mg tablet, sublingually (SL) twice daily (BID) for 182 days
Other Name: Saphris®, SCH 900274, Org 5222, Sycrest®
|
|
Experimental: Asenapine 10 mg
Participants who were randomized to asenapine 10 mg BID during the P05691 study will be assigned to receive asenapine 10 mg BID on this extension study.
|
Drug: asenapine
asenapine 10 mg tablet, SL BID for 182 days
Other Name: Saphris®, SCH 900274, Org 5222, Sycrest®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Each participant must have completed the short-term trial P05691, and be judged by the investigator to likely benefit from continued treatment
- Each participant must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the short-term trial P05691
Exclusion criteria:
- A participant must not have had any adverse event or other clinically significant finding(s) in the short-term trial P05691 that would prohibit the subject's continuation into this long-term extension trial
- A participant must not have any newly diagnosed or discovered psychiatric condition that would have excluded the subject from participation in the short-term trial P05691
- A participant must not be at imminent risk of self-harm or harm to others
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395992
Contacts
| Contact: Toll Free Number | 1-888-577-8839 |
Locations
| United States, Arkansas | |
| Call for Information (Investigational Site 1024) | Recruiting |
| Little Rock, Arkansas, United States, 72211 | |
| United States, California | |
| Call for Information (Investigational Site 1013) | Recruiting |
| Cerritos, California, United States, 90703 | |
| Call for Information (Investigational Site 1020) | Recruiting |
| Costa Mesa, California, United States, 92626 | |
| Call for Information (Investigational Site 1027) | Recruiting |
| Garden Grove, California, United States, 92845 | |
| Call for Information (Investigational Site 1012) | Recruiting |
| Pico Rivera, California, United States, 90660 | |
| Call for Information (Investigational Site 1021) | Recruiting |
| San Diego, California, United States, 92102 | |
| Call for Information (Investigational Site 1006) | Recruiting |
| San Diego, California, United States, 92121 | |
| Call for Information (Investigational Site 1016) | Recruiting |
| San Diego, California, United States, 92123 | |
| United States, District of Columbia | |
| Call for Information (Investigational Site 1010) | Recruiting |
| Washington, District of Columbia, United States, 20016 | |
| United States, Florida | |
| Call for Information (Investigational Site 1023) | Recruiting |
| Bradenton, Florida, United States, 34208 | |
| Call for Information (Investigational Site 1025) | Recruiting |
| Fort Lauderdale, Florida, United States, 33301 | |
| Call for Information (Investigational Site 1019) | Recruiting |
| Ft. Lauderdale, Florida, United States, 33308 | |
| Call for Information (Investigational Site 1007) | Recruiting |
| Maitland, Florida, United States, 32751 | |
| United States, Louisiana | |
| Call for Information (Investigational Site 1028) | Recruiting |
| Lake Charles, Louisiana, United States, 70629 | |
| United States, Mississippi | |
| Call for Information (Investigational Site 1008) | Recruiting |
| Flowood, Mississippi, United States, 39232 | |
| United States, Missouri | |
| Call for Information (Investigational Site 1014) | Recruiting |
| St. Louis, Missouri, United States, 63118 | |
| United States, New Jersey | |
| Call for Information (Investigational Site 1005) | Recruiting |
| Willingboro, New Jersey, United States, 08046 | |
| United States, Ohio | |
| Call for Information (Investigational Site 1026) | Recruiting |
| Dayton, Ohio, United States, 45408 | |
| United States, Pennsylvania | |
| Call for Information (Investigational Site 1015) | Recruiting |
| Philadelphia, Pennsylvania, United States, 19139 | |
| United States, Texas | |
| Call for Information (Investigational Site 1000) | Recruiting |
| Austin, Texas, United States, 78754 | |
| Call for Information (Investigational Site 1004) | Recruiting |
| Austin, Texas, United States, 78731 | |
| Call for Information (Investigational Site 1002) | Recruiting |
| Dallas, Texas, United States, 75231 | |
Sponsors and Collaborators
Merck
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01395992 History of Changes |
| Other Study ID Numbers: | P05692, 2010-018410-78 |
| Study First Received: | July 14, 2011 |
| Last Updated: | May 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Asenapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 18, 2013