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NCT00253968 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
967
Enrollment target

NCT00253968 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 967 participants.

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The verdict

NCT00253968, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
967 participants
Enrollment target

Study Summary

The purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.

Interventions

  • DRUG placebo
  • DRUG Eplivanserin

Trial Details

FieldValue
Enrollment Target 967 participants
Start Date 2005-11
Est. Completion 2008-01
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00253968

The ClinicalTrials.gov registry entry for NCT00253968 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 967 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.

NCT00253968 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00253968 about?

NCT00253968 is a clinical study titled "Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia". The purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress...

What is the current status of trial NCT00253968?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 967 participants. The study started on 2005-11. Estimated completion is 2008-01.

What interventions are being tested in trial NCT00253968?

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

Who is sponsoring clinical trial NCT00253968?

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.