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Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689)

NCT01617200 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2015-05-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Asenapine

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

DRUG

Placebo Asenapine

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

DRUG

Olanzapine

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.

DRUG

Placebo Olanzapine

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.

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01617200 on ClinicalTrials.gov