Status:
TERMINATED
A Weight Maintenance Study in Obese Patients (0364-012)(TERMINATED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in obese patients.
Eligibility Criteria
Inclusion
- Patient has a body mass index (BMI) between 30 kg/m² and 43kg/m² and has maintained a stable weight (+/- 3kg) for at least 3 months prior to study start
- Patient is male or female \>=18 and \<= 65 years of age
- Patient understands the study procedures and alternative treatments available
- Patient is able to read, understand and complete study questionnaires
Exclusion
- Patient has a history or presence of a major psychiatric disorder
- Patient has a recent history (within 6 months prior to signing the informed consent) diagnosis/episode/recurrence of stroke, TIA or neurological disorder
- Patient has a history of seizures or is at high risk of developing seizures
- Patient has systolic blood pressure \>160mm Hg or diastolic blood pressure \> 100 mm Hg
- Patient has diabetes mellitus as defined by medical history
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00420589
Start Date
October 1 2006
End Date
November 1 2008
Last Update
February 5 2015
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