Status:
TERMINATED
Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Sleep Initiation and Maintenance Disorders
Mental Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 (NCT006316...
Eligibility Criteria
Inclusion
- Sign written informed consent
- Completed clinical trial 21106/P05701/MK-8265-002
Exclusion
- 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
Key Trial Info
Start Date :
October 7 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2010
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT00750919
Start Date
October 7 2008
End Date
March 10 2010
Last Update
February 2 2021
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