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

NCT00464243 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 604

Last updated 2017-08-08

No results posted yet for this 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.

Conditions

  • Sleep Initiation and Maintenance Disorders

Interventions

DRUG

volinanserin

oral administration

DRUG

placebo

oral administration

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • France
  • Germany
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00464243 on ClinicalTrials.gov