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Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia

NCT00671255 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 829

Last updated 2012-02-28

No results posted yet for this study

Summary

This purpose of this study is to evaluate the safety and effectiveness of Ramelteon, once daily (QD), in elderly participants with chronic insomnia.

Conditions

  • Chronic Insomnia

Interventions

DRUG

Ramelteon

Ramelteon 4 mg, tablets, orally, once daily for up to 5 weeks.

DRUG

Ramelteon

Ramelteon 8 mg, tablets, orally, once daily for up to 5 weeks.

DRUG

Placebo

Ramelteon placebo-matching, tablets, orally, each night for up to 35 consecutive days.

Sponsors & Collaborators

Principal Investigators

  • VP Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2004-01-31
Completion
2004-01-31

Countries

  • United States
  • 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 NCT00671255 on ClinicalTrials.gov