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NCT00464243 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic Study

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
604
Enrollment target

NCT00464243 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 604 participants.

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The verdict

NCT00464243, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
604 participants
Enrollment target

Study Summary

The purpose of this study is to assess efficacy and safety of volinanserin 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 non restorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.

Interventions

  • DRUG placebo
  • DRUG volinanserin

Trial Details

FieldValue
Enrollment Target 604 participants
Start Date 2007-04
Est. Completion 2008-01
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00464243

The ClinicalTrials.gov registry entry for NCT00464243 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 604 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.

NCT00464243 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00464243 about?

NCT00464243 is a clinical study titled "Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic Study". The purpose of this study is to assess efficacy and safety of volinanserin 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 non restorative and they suffer from a significant distre...

What is the current status of trial NCT00464243?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 604 participants. The study started on 2007-04. Estimated completion is 2008-01.

What interventions are being tested in trial NCT00464243?

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

Who is sponsoring clinical trial NCT00464243?

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.