CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 346 enrolled
Drug / intervention
Org 50081drug
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/NCT00610675
NCT00610675Phase 3Completed
CompareCT.gov

Fifty-Two Weeks, Open Label Extension Trial to Evaluate Safety and Efficacy of Org 50081 in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 176001 or 176002.

Merck Sharp & Dohme LLC·interventional·Posted Feb 8, 2008·Updated Oct 3, 2018

In Brief

A Phase 3 clinical trial evaluating Org 50081 for Insomnia. Completed, enrolled 346 participants.

Detailed Summary

This trial is a 52-week, open-label extension trial to investigate safety and to explore efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706) (NCT00482612) or 176002 (P05707) (NCT00506389). Participants who have completed Protocol P05706 or P05707, and are willing to continue treatment with Esmirtazapine, can participate in Protocol 176004 (P05708) after signing informed consent.

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2008
Enrollment StartDec 7, 2006
Primary CompletionAug 17, 2009
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 18.4 years ago

Interventions

Org 50081drug

One tablet daily