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NCT01058096 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Cariprazine for Mania

A Phase 3 study, sponsored by Forest Laboratories.

Completed
Registry status
Phase 3
Development phase
323
Enrollment target

NCT01058096 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 323 participants.

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The verdict

NCT01058096, a Phase 3 study, has completed, sponsored by Forest Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
323 participants
Enrollment target

Study Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.

Interventions

  • DRUG Placebo
  • DRUG Cariprazine

Trial Details

FieldValue
Enrollment Target 323 participants
Start Date 2010-02
Est. Completion 2011-07
Phase Phase 3

Sponsor

Forest Laboratories

145 total trials

What the Registry Record Tells You About NCT01058096

The ClinicalTrials.gov registry entry for NCT01058096 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 323 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01058096 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01058096 about?

NCT01058096 is a clinical study titled "Safety and Efficacy of Cariprazine for Mania". The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.

What is the current status of trial NCT01058096?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 323 participants. The study started on 2010-02. Estimated completion is 2011-07.

What interventions are being tested in trial NCT01058096?

The interventions under investigation include: Placebo (DRUG), Cariprazine (DRUG).

Who is sponsoring clinical trial NCT01058096?

This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.