Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)

NCT ID: NCT00750919

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-07
• Study Completion Date: 2010-03-10

Brief Summary

This trial is a 26-week, open label extension trial to investigate safety and explore efficacy of esmertazapine in participants with insomnia who completed protocol 21106/P05701/MK-8265-002 (NCT00631657).

Conditions

Sleep Initiation and Maintenance Disorders; Mental Disorders; Dyssomnias; Sleep Disorders; Sleep Disorders, Intrinsic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Esmirtazapine

Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months.

Group Type: EXPERIMENTAL

esmirtazapine

Intervention Type: DRUG

Interventions

esmirtazapine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Sign written informed consent
• Completed clinical trial 21106/P05701/MK-8265-002

Exclusion Criteria

• Any (serious) adverse event, medical condition or required concomitant medication deemed relevant for exclusion in trial 21106/P05071/MK-8265-002 as judged by the investigator
• Were significantly non compliant with protocol criteria and procedures of trial 21106/P05701/MK-8265-002, as judged by the investigator
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Ivgy-May N, Hajak G, van Osta G, Braat S, Chang Q, Roth T. Efficacy and safety of esmirtazapine in adult outpatients with chronic primary insomnia: a randomized, double-blind placebo-controlled study and open-label extension. J Clin Sleep Med. 2020 Sep 15;16(9):1455-1467. doi: 10.5664/jcsm.8526.

Reference Type: DERIVED

PMID: 32351205 (View on PubMed)

Other Identifiers

176003

Identifier Type: OTHER

Identifier Source: secondary_id

2007-005237-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P05721

Identifier Type: -

Identifier Source: org_study_id