drugset / Trial / NCT00561821
Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709)
RandomizedParallel-groupTriple-blindTreatment
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esmirtazapine | Small molecule | 0.5 mg | — |
| Subject | Esmirtazapine | Small molecule | 1.5 mg | — |
| Subject | Esmirtazapine | Small molecule | 3 mg | — |