Status:
TERMINATED
An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A 1 year worldwide study in obese and overweight patients to assess the safety and effect on body weight of an investigational weight loss drug.
Eligibility Criteria
Inclusion
- Male or female, 18 years of age or older, with Body Mass Index (BMI) between 30 kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive, for those with obesity-related comorbidities). Obesity-related comorbidities associated with a BMI of 27 kg/m2 or higher include hypertension, dyslipidemia or sleep apnea
- Stable weight (+/-3 kg) for at least 3 months prior to study start
Exclusion
- History of diabetes mellitis, major psychiatric disorder, significant cardiovascular disease, stroke, TIA, neurological disorder, non-febrile seizures
- Screening systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00384605
Start Date
October 1 2006
End Date
December 1 2008
Last Update
March 13 2015
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