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A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)

NCT00631657 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2018-10-02

Study results available
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Summary

To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081, SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia. Primary efficacy variable is Total Sleep Time (TST).

Conditions

  • Sleep Initiation and Maintenance Disorders
  • Mental Disorders
  • Dyssomnias
  • Sleep Disorders
  • Sleep Disorder, Intrinsic

Interventions

DRUG

Esmirtazapine

One esmirtazapine 4.5 mg tablet once a day

DRUG

Placebo

One placebo tablet once a day

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-04
Primary Completion
2009-11-19
Completion
2009-11-19

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Entities

Drugs
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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 NCT00631657 on ClinicalTrials.gov