drugset / Trial / NCT00482612

Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)

NCT00482612

Phase 3 Completed 526 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2006-12-07
Primary completion
2008-08-11
Completion
2008-08-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Esmirtazapine Small molecule 1.5 mg Oral
Subject Esmirtazapine Small molecule 3 mg Oral
Subject Esmirtazapine Small molecule 4.5 mg Oral

Indications