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NCT00308503 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
608
Enrollment target

NCT00308503 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 608 participants.

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The verdict

NCT00308503, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
608 participants
Enrollment target

Study Summary

The aim of the study is to confirm the efficacy of eplivanserin 5mg/day on sleep maintenance of patients with primary insomnia using night polysomnography recordings over a 6-week treatment period corresponding to a stabilization of improvement of sleep.

Interventions

  • DRUG placebo
  • DRUG eplivanserin (SR46349)

Trial Details

FieldValue
Enrollment Target 608 participants
Start Date 2006-02
Est. Completion 2007-08
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00308503

The ClinicalTrials.gov registry entry for NCT00308503 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 608 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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

NCT00308503 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00308503 about?

NCT00308503 is a clinical study titled "Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia". The aim of the study is to confirm the efficacy of eplivanserin 5mg/day on sleep maintenance of patients with primary insomnia using night polysomnography recordings over a 6-week treatment period corresponding to a stabilization of improvement of sleep.

What is the current status of trial NCT00308503?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 608 participants. The study started on 2006-02. Estimated completion is 2007-08.

What interventions are being tested in trial NCT00308503?

The interventions under investigation include: placebo (DRUG), eplivanserin (SR46349) (DRUG).

Who is sponsoring clinical trial NCT00308503?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

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

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.