Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709)

Insomnia Clinical Trial

Official title: A Double-Blind, Randomized, Parallel Group, Placebo- Controlled Sleep Laboratory Efficacy and Safety Study With Org 50081 in Elderly Subjects With Chronic Primary Insomnia

Status Completed

Clinical Trial Summary

This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine)

compared to placebo in elderly participants with chronic primary

insomnia. Primary efficacy variable is Wake time After Sleep

Onset (WASO), averaged over all in-treatment time points

and measured by polysomnography (PSG).

Clinical Trial Description

Insomnia is a common complaint or disorder throughout the

world. About one third of the population in the industrial

countries reports difficulty initiating or maintaining sleep,

resulting in a non-refreshing or non-restorative sleep. The

majority of the insomniacs suffer chronically from their

complaints.

The maleic acid salt of Org 4420, code name Org 50081, known as Esmirtazapine, was

selected for development in the treatment of insomnia. The

first clinical trial with Esmirtazapine was a proof-of-concept trial

with a four-way cross-over design. All 3 Esmirtazapine dose

groups showed a statistically significant positive effect on

TST (objective and subjective) and WASO, as compared to

placebo.

The current study is designed to assess the efficacy and safety

of Esmirtazapine in a double-blind, placebo-controlled, parallel,

randomized trial in elderly participants suffering from chronic

primary insomnia. ;

Related Conditions & MeSH terms

• Disease
• Dyssomnias
• Insomnia
• Mental Disorders
• Parasomnias
• Psychotic Disorders
• Sleep Disorders
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

• NCT number: NCT00561821
• Study type: Interventional
• Source: Merck Sharp & Dohme Corp.
• Status: Completed
• Phase: Phase 3
• Start date: November 20, 2007
• Completion date: December 21, 2009