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

NCT00308503 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 608

Last updated 2010-11-30

No results posted yet for this 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.

Conditions

  • Sleep Initiation and Maintenance Disorders
  • Insomnia

Interventions

DRUG

eplivanserin (SR46349)

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
2006-02-28
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00308503 on ClinicalTrials.gov