Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01059539 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder
A Phase 3 study of Bipolar I Disorder, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 403
- Enrollment target
- 20
- Study locations
NCT01059539 is a Phase 3 study of Bipolar I Disorder that has completed, run by Forest Laboratories. The registered enrollment target is 403 participants, above the 314-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 11 states.
The verdict
NCT01059539, a Phase 3 study of Bipolar I Disorder, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 403 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Cariprazine
Study Locations (20)
California
- Forest Investigative Site 010 - Carson
- Forest Investigative Site 020 - Cerritos
- Forest Investigative Site 009 - Escondido
- Forest Investigative Site 004 - Garden Grove
- Forest Investigative Site 016 - San Diego
- Forest Investigative Site 007 - Santa Ana
Florida
- Forest Investigative Site 001 - Bradenton
- Forest Investigative Site 006 - Fort Lauderdale
- Forest Investigative Site 013 - Kissimmee
Missouri
- Forest Investigative Site 022 - Creve Coeur
- Forest Investigative Site 003 - Saint Charles
- Forest Investigative Site 025 - St Louis
Arkansas
- Forest Investigative Site 015 - Springdale
District of Columbia
- Forest Investigative Site 023 - Washington D.C.
Maryland
- Forest Investigative Site 021 - Rockville
Mississippi
- Forest Investigative Site 024 - Flowood
Nevada
- Forest Investigative Site 012 - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 403 participants |
| Start Date | 2010-02-28 |
| Est. Completion | 2012-02-29 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01059539
The ClinicalTrials.gov registry entry for NCT01059539 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 403 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 314-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target (28% higher). The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bipolar I Disorder appearing as the primary indexed condition, and to 1 intervention - of which Cariprazine is the first listed.
NCT01059539 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT01059539 about?
NCT01059539 is a clinical study titled "Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder". The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.
What is the current status of trial NCT01059539?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 403 participants. The study started on 2010-02-28. Estimated completion is 2012-02-29.
What conditions does trial NCT01059539 study?
This clinical trial studies the following conditions: Bipolar I Disorder.
What interventions are being tested in trial NCT01059539?
The interventions under investigation include: Cariprazine (DRUG).
Who is sponsoring clinical trial NCT01059539?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01059539 being conducted?
This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar I Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
RECRUITING · Phase 3
-
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
RECRUITING · Phase 3
-
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
RECRUITING · Phase 3
-
Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex
COMPLETED · Phase 3
-
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode
COMPLETED · Phase 3
-
Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.