Trials / Completed
CompletedNCT00561574
A Long-Term Safety Study of Org 50081 (Esmirtazapine) in Elderly Outpatients With Chronic Primary Insomnia (176005/P05697/MK-8265-001)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 259 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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 (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 Total Sleep Time (TST) (objective and subjective) and Wake Time After Sleep Onset (WASO), as compared to placebo. 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 to investigate the safety and tolerability of long-term treatment with esmirtazapine in elderly patients.
Conditions
- Sleep Initiation and Maintenance Disorder; Elderly
- Mental Disorder
- Dyssomnias
- Sleep Disorders
- Sleep Disorder, Intrinsic
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Esmirtazapine | One tablet daily |
Timeline
- Start date
- 2008-01-09
- Primary completion
- 2010-02-14
- Completion
- 2010-02-14
- First posted
- 2007-11-21
- Last updated
- 2021-01-27
- Results posted
- 2014-07-07
Source: ClinicalTrials.gov record NCT00561574. Inclusion in this directory is not an endorsement.