At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 460 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.
A 6-Month, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Outpatient Trial, Investigating the Efficacy and Safety of Org 50081 in Adult Patients With Chronic Primary Insomnia
In Brief
A Phase 3 clinical trial evaluating Esmirtazapine and Placebo for Sleep Initiation and Maintenance Disorders and 4 related conditions. Completed, enrolled 460 participants.
Detailed Summary
To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081, SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia. Primary efficacy variable is Total Sleep Time (TST).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias, Sleep Disorders, Sleep Disorder, Intrinsic
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2008
First PostedMar 2008
Primary CompletionNov 2009
TodayJul 2026
First PostedMar 10, 2008
Enrollment StartMar 4, 2008
Primary CompletionNov 19, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.3 years ago
Interventions
Esmirtazapinedrug
One esmirtazapine 4.5 mg tablet once a day
Placebodrug
One placebo tablet once a day