Status:
COMPLETED
Fifty Two Week Extension Trial of Org 50081 (Esmirtazapine) in the Treatment of Insomnia (P05708)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Insomnia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 1...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 7 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2009
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT00610675
Start Date
December 7 2006
End Date
August 17 2009
Last Update
October 3 2018
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