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Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia

NCT00630175 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2009-05-18

No results posted yet for this study

Summary

The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release) 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with primary insomnia and sleep maintenance difficulties, using polysomnography (PSG) recordings and patient sleep questionnaires.

The secondary objective is to evaluate the clinical safety and tolerability of zolpidem-MR 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo.

Conditions

  • Sleep Initiation and Maintenance Disorders

Interventions

DRUG

zolpidem-MR (modified release)

DRUG

zolpidem (SL800750)

DRUG

placebo

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2004-02-29
Completion
2004-02-29

Countries

  • United States
  • Australia
  • Canada

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 NCT00630175 on ClinicalTrials.gov