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Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus

NCT00495885 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 848

Last updated 2016-05-26

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 objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus.

Conditions

  • Sleep Initiation and Maintenance Disorders

Interventions

DRUG

volinanserin (M100907)

oral, one tablet taken around bedtime

DRUG

Placebo

oral, one tablet taken around bedtime

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States
  • Brazil
  • Canada
  • Colombia
  • Czechia
  • Finland
  • France
  • Greece
  • Italy
  • Malaysia
  • Netherlands
  • Russia
  • South Africa
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)

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 NCT00495885 on ClinicalTrials.gov