Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689)
A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine Using Olanzapine as an Active Control in Subjects Diagnosed With Schizophrenia Who Completed Protocol P05688
2 other identifiers
interventional
105
1 country
1
Brief Summary
Participants who have completed the 6-week trial P05688 can be screened for eligibility for this 26-week extension study in which they will continue treatment. The purpose of this trial is to evaluate the long-term safety of 2.5 and 5 mg asenapine administered sublingually twice daily (BID) in schizophrenia participants. Olanzapine administered 15 mg orally once daily (QD) is used as an active control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 schizophrenia
Started Dec 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2012
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMay 27, 2015
May 1, 2015
2.2 years
June 8, 2012
May 26, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Weight From Baseline to Day 182
Baseline (Day -1 of Short Term Trial) to Day 182 (Long-Term Extension)
Study Arms (4)
Asenapine 2.5 mg BID
EXPERIMENTALAsenapine 5 mg BID
EXPERIMENTALOlanzapine 15 mg QD
ACTIVE COMPARATORPlacebo switched to Asenapine 2.5 mg BID
EXPERIMENTALInterventions
2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening
2.5 mg or 5 mg fast dissolving placebo asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening
15 mg film-coated active olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.
15 mg film-coated placebo olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.
Eligibility Criteria
You may qualify if:
- Completed the short-term trial P05688, and judged by the investigator likely to benefit from continued treatment
You may not qualify if:
- Occurrence(s) of an adverse event or other clinically significant finding(s) in the short-term trial P05688 that would prohibit the participant's continuation into the long-term extension
- Clinical Global Impression-Severity of Illness (CGI-S) score of ≥6 (severely psychotic) at Baseline
- Newly diagnosed or discovered psychiatric condition that would have excluded the participant from participation in the short-term trial P05688
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Forest Investigative Site 2001
Austin, Texas, 78754, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2012
First Posted
June 12, 2012
Study Start
December 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
May 27, 2015
Record last verified: 2015-05