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

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).

Timeline

Start

2007-11-20

Primary completion

2009-12-21

Completion

2009-12-21

Outcome

Met primary endpoint

registry Esmirtazapine 3.0 mg vs Placebo; p <0.0001; ANCOVA NCT00561821 ↗

Drugs

Indications