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NCT01677182 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder

A Phase 3 study, sponsored by Takeda.

Terminated
Registry status
Phase 3
Development phase
535
Enrollment target

NCT01677182 is a Phase 3 study that was terminated before completion, run by Takeda. The registered enrollment target is 535 participants.

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The verdict

NCT01677182, a Phase 3 study, was terminated before completion, sponsored by Takeda.

TERMINATED
Registry status
Phase 3
Development phase
535 participants
Enrollment target

Study Summary

To evaluate the efficacy of ramelteon for treatment of acute depressive episodes associated with Bipolar 1 Disorder.

Interventions

  • DRUG Placebo
  • DRUG Ramelteon

Trial Details

FieldValue
Enrollment Target 535 participants
Start Date 2012-08
Est. Completion 2014-09
Phase Phase 3

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT01677182

The ClinicalTrials.gov registry entry for NCT01677182 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 535 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

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

NCT01677182 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01677182 about?

NCT01677182 is a clinical study titled "Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder". To evaluate the efficacy of ramelteon for treatment of acute depressive episodes associated with Bipolar 1 Disorder.

What is the current status of trial NCT01677182?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 535 participants. The study started on 2012-08. Estimated completion is 2014-09.

What interventions are being tested in trial NCT01677182?

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

Who is sponsoring clinical trial NCT01677182?

This trial is sponsored by Takeda, which has 408 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.