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

NCT00561821 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 538

Last updated 2018-10-03

Study results available
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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).

Conditions

  • Insomnia
  • Sleep Initiation and Maintenance Disorders
  • Mental Disorders
  • Dyssomnias
  • Sleep Disorders

Interventions

DRUG

Esmirtazapine

one tablet daily

DRUG

Placebo

one tablet daily

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-20
Primary Completion
2009-12-21
Completion
2009-12-21

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00561821 on ClinicalTrials.gov