CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 419 enrolled
Drug / intervention
Esmirtazapine +1 moredrug
Likely dose
Esmirtazapine 3.0 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/NCT00506389
NCT00506389Phase 3Completed
CompareCT.gov

A Six-Week Double-Blind Randomized, Placebo-Controlled, Parallel Group, Efficacy and Safety, Sleep Lab Trial With Org 50081 in Patients With Chronic Primary Insomnia

Merck Sharp & Dohme LLC·interventional·Posted Jul 25, 2007·Updated Oct 2, 2018

In Brief

A Phase 3 clinical trial evaluating Esmirtazapine and Placebo for Insomnia. Completed, enrolled 419 participants.

Detailed Summary

The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 25, 2007
Enrollment StartJun 6, 2007
Primary CompletionFeb 13, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.9 years ago

Interventions

Esmirtazapinedrug

Esmirtazapine maleate was provided as tablets for oral use containing 3.0 mg, 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.

Placebodrug

The placebo tablets contained the following excipients: hydroxypropyl cellulose, maize starch (USP name corn starch), magnesium stearate, and lactose monohydrate.