CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 526 enrolled
Drug / intervention
Esmirtazapine +1 moredrug
Likely dose
Esmirtazapine 4.5 mgfrom 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/NCT00482612
NCT00482612Phase 3Completed
CompareCT.gov

A Two-Week, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Efficacy and Safety Out-Patient Trial With Org 50081 in Patients With Chronic Primary Insomnia

Merck Sharp & Dohme LLC·interventional·Posted Jun 5, 2007·Updated Oct 3, 2018

In Brief

A Phase 3 clinical trial evaluating Esmirtazapine and Placebo for Insomnia. Completed, enrolled 526 participants.

Detailed Summary

The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 5, 2007
Enrollment StartDec 7, 2006
Primary CompletionAug 11, 2008
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.1 years ago

Interventions

Esmirtazapinedrug

Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia \[USP\] name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.

Placebodrug

Placebo tablets containing the following excipients: hydroxypropyl cellulose, maize starch (USP name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.