Fifty Two Week Extension Trial of Org 50081 (Esmirtazapine) in the Treatment of Insomnia (P05708)

NCT ID: NCT00610675

Last Updated: 2018-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-07
• Study Completion Date: 2009-08-17

Brief Summary

This trial is a 52-week, open-label extension trial to investigate safety and to explore efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706) (NCT00482612) or 176002 (P05707) (NCT00506389). Participants who have completed Protocol P05706 or P05707, and are willing to continue treatment with Esmirtazapine, can participate in Protocol 176004 (P05708) after signing informed consent.

Conditions

Insomnia

Study Design

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

Study Groups

Esmirtazapine

One tablet of Esmirtazapine, 4.5 mg orally, daily for up to 52 weeks

Group Type: EXPERIMENTAL

Org 50081

Intervention Type: DRUG

One tablet daily

Interventions

Org 50081

One tablet daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• sign written informed consent after the scope and nature of the investigation have been explained to them, before any trial-related evaluations;
• completed Protocol P05706 or P05707;
• Have safety and efficacy assessments conducted per protocol P05706 or P05707.

Exclusion Criteria

• clinically relevant electrocardiogram (ECG) abnormalities as judged by the investigator;
• clinically relevant abnormal laboratory values as judged by the investigator;
• any adverse event deemed relevant for exclusion in Protocol P05708 as judged by the investigator or,
• were significantly non compliant with protocol criteria and procedures of Protocol P05706 or P05707, as judged by the investigator.

• 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

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

176004

Identifier Type: -

Identifier Source: secondary_id

P05708

Identifier Type: -

Identifier Source: org_study_id