CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 538 enrolled
Drug / intervention
Esmirtazapine +1 moredrug
Likely dose
Not stated in 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/NCT00561821
NCT00561821Phase 3Completed
CompareCT.gov

A Double-Blind, Randomized, Parallel Group, Placebo- Controlled Sleep Laboratory Efficacy and Safety Study With Org 50081 in Elderly Subjects With Chronic Primary Insomnia

Merck Sharp & Dohme LLC·interventional·Posted Nov 21, 2007·Updated Oct 3, 2018

In Brief

A Phase 3 clinical trial evaluating Esmirtazapine and Placebo for Insomnia and 4 related conditions. Completed, enrolled 538 participants.

Detailed Summary

This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine) compared to placebo in elderly participants with chronic primary insomnia. Primary efficacy variable is Wake time After Sleep Onset (WASO), averaged over all in-treatment time points and measured by polysomnography (PSG).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia, Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias, Sleep Disorders
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 21, 2007
Enrollment StartNov 20, 2007
Primary CompletionDec 21, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.6 years ago

Interventions

Esmirtazapinedrug

one tablet daily

Placebodrug

one tablet daily