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Safety of Ramelteon in Elderly Subjects

NCT00568789 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2012-02-28

No results posted yet for this study

Summary

The purpose of this study is to investigate the effects of ramelteon in elderly subjects on balance, mobility and memory impairment after awakening in the middle of the night following bedtime dosing.

Conditions

Interventions

DRUG

Ramelteon, zolpidem and placebo

Ramelteon 8 mg, tablets, orally, one night only during Period 1, 2 or 3 Zolpidem 10 mg, tablets, orally, one night only during Period 1, 2 or 3 Ramelteon/Zolpidem placebo-matching tablets, orally one night only during Period 1, 2 or 3

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2006-09-30
Completion
2006-09-30

Countries

  • United States

Study Locations

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Entities

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 NCT00568789 on ClinicalTrials.gov