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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 3

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

Treatments: Drug: esmirtazapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00750919

2007-005237-10 (EudraCT Number)

176003 (Other Identifier)

P05721

Details and patient eligibility

About

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).

Enrollment: 184 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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184 participants in 1 patient group

Esmirtazapine

Experimental group

Description:

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

Treatment:

Drug: esmirtazapine