CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 27 enrolled
Drug / intervention
rozerem +1 moredrug
Likely dose
rozerem 8mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01048242
NCT01048242Phase 3Completed
CompareCT.gov

Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)

University of Pennsylvania·interventional·Posted Jan 13, 2010·Updated May 25, 2023

In Brief

A Phase 3 clinical trial evaluating rozerem and Placebo for Insomnia and Obstructive Sleep Apnea. Completed, enrolled 27 participants across 1 site.

Detailed Summary

The objective of the study is to determine if treatment with Ramelteon will help to improve insomnia in older adults with co-existent insomnia and sleep apnea. The primary study objective is sleep latency (a measure of insomnia). The hypothesis is that sleep latency will be reduced in subjects taking Ramelteon relative to the placebo arm. The secondary study objective is to determine if subject compliance with CPAP treatment of their sleep apnea is improved in subjects taking Ramelteon (their compliance may be improved because they would have less insomnia due to Ramelteon treatment when using their CPAP). The hypothesis is that compliance with CPAP will be improved in subjects taking Ramelteon relative to the placebo arm.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia, Obstructive Sleep Apnea
CountriesUnited States
CollaboratorsTakeda

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 13, 2010
Enrollment StartJul 1, 2006
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 16.5 years ago

Interventions

rozeremdrug

Ramelteon (rozerem) 8mg oral before bedtime

Placebodrug

placebo