At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 259 enrolled
Drug / intervention
Esmirtazapinedrug
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.
A Randomized Long-Term Safety Study of Org 50081 in Elderly Outpatients With Chronic Primary Insomnia Examining the Effects of 1.5 mg or 3.0 mg of Org 50081
In Brief
A Phase 3 clinical trial evaluating Esmirtazapine for Sleep Initiation and Maintenance Disorder; Elderly and 4 related conditions. Completed, enrolled 259 participants.
Detailed Summary
The current study is a 52-week safety study in elderly outpatients with chronic primary insomnia randomized to treatment with 1.5 mg or 3.0 mg of esmirtazapine (Org 50081, SCH 900265, MK-8265) to investigate the safety and tolerability of long-term treatment with esmirtazapine in elderly patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Initiation and Maintenance Disorder; Elderly, Mental Disorder, Dyssomnias, Sleep Disorders, Sleep Disorder, Intrinsic
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2007
Enrollment StartJan 2008
Primary CompletionFeb 2010
TodayJul 2026
First PostedNov 21, 2007
Enrollment StartJan 9, 2008
Primary CompletionFeb 14, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.6 years ago
Interventions
Esmirtazapinedrug
One tablet daily