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Long-Term Efficacy of Ramelteon on Endocrine Function in Adult Subjects With Chronic Insomnia

NCT00656994 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2012-02-28

No results posted yet for this study

Summary

The purpose of this study is to determine the long-term effects of Ramelteon, once daily (QD), on endocrine function values.

Conditions

Interventions

DRUG

Ramelteon

Ramelteon 16 mg, tablets, orally, once nightly for up to 6 months.

DRUG

Placebo

Ramelteon placebo-matching tablets, orally, once nightly for up to 6 months

Sponsors & Collaborators

Principal Investigators

  • VP Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2004-07-31
Completion
2004-07-31

Countries

  • United States

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 NCT00656994 on ClinicalTrials.gov