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Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Study P06125)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Asenapine (Drug); Asenapine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

This is a multi-site, randomized fixed-flexible dose long-term study of asenapine in participants with schizophrenia. The first six weeks of the study will be double-blind and the remainder of the study will be open label. Participants in this study consist of participants who have completed the preceding short-term study (P06124), who meet the inclusion criteria and wish to continue receiving study drug, and whom the investigators have deemed eligible for study participation. Participants who were on placebo bid in core trial P06124 will get placebo for the first 2 weeks then 5 mg asenapine for the next 4 weeks of double blind treatment, and will be re-randomized after week 6 to asenapine 5 mg bid or asenapine 10 mg bid. Participants who were on asenapine 5 mg bid in core trial P06124 will be re-randomized after Week 6 to asenapine 5 mg twice daily (bid) or asenapine 10 mg bid Participants who were on asenapine 10 mg twice daily (bid) in core trial P06124 will be re-randomized after Week 6 to asenapine 5 mg bid or asenapine 10 mg bid

Clinical Details

Official title: Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Phase 3 ; Protocol No. P06125)

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Weight gain/loss from baseline

Change in Body Mass Index (BMI) from baseline

Occurrences of extrapyramidal symptoms (EPS)

Change in fasting glucose from baseline

Change in insulin from baseline

Changes in prolactin level from baseline

Occurrences of serious and non-serious adverse events

Participants who had findings on physical exam out of normal range

Participants who had vital sign findings out of normal range

Participants who had abnormal electrocardiogram (ECG) findings

Occurrences of abnormal laboratory findings

Change in drug-induced extrapyramidal symptom scale (DIEPSS) from baseline

Number of participants taking anti-Parkinson drugs

Amount of anti-Parkinson drugs

Change in glycosylated hemoglobin (HbA1c) from baseline

Eligibility

Minimum age: 20 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participant has completed 42-day drug administration in the preceding short-term

study (Protocol P06124), has exhibited efficacy (aCGI-I at the completion of the preceding short-term study of markedly improved, moderately improved, or slightly improved), has no significant safety problems, and has been judged appropriate for study participation by the investigator.

- Male and female participants. Women who are of childbearing potential (i. e., not

surgically sterile or post menopausal for at least 1 year) must use medically acceptable birth control. Medically acceptable birth control includes condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, insert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation). Male participants must agree to use condoms during their participation in the study.

- Participant must have been explained the nature of the study by the investigator, and

be able to provide written consent prior to the conduct of the tests/observation of the clinical study. Exclusion Criteria:

- A participant must not have any clinically significant abnormal laboratory, vital

sign, physical examination, or electrocardiogram (ECG) findings that, in the investigator's opinion, preclude the participant's participation in the study

- A participant must not have a positive pregnancy test or be planning to become

pregnant during the term of the study;

- A participant must not receive antipsychotics, antidepressants, mood stabilizers,

anti-epileptics, monoamine oxidase inhibitors, St. John's Wort, antiemetics that are dopamine agonist, or traditional herbal medication for psychiatric symptoms at the baseline;

- A participant must not be at risk of harming themselves or others, in the

investigator's opinion;

- A participant must not have been determined to be unsuitable by an investigator.

Locations and Contacts

Additional Information

Starting date: May 2010
Last updated: August 18, 2015

Page last updated: August 23, 2015

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