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Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder

NCT01059539 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2019-06-13

Study results available
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Summary

The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.

Conditions

Interventions

DRUG

Cariprazine

Cariprazine was supplied in capsules.

Sponsors & Collaborators

  • Gedeon Richter Ltd.

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Elizabeth Diaz, MD · Forest Laboratories

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States
  • Hungary
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

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 NCT01059539 on ClinicalTrials.gov