Status:
COMPLETED
Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the effects of canagliflozin and phentermine to those of placebo to promote on a change in body weight over a 26 week period.
Detailed Description
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substa...
Eligibility Criteria
Inclusion
- Must have BMI \>=30 kg/m2 and \<50 kg/m2 at screening or BMI \>=27 kg/m2 and \<50 kg/m2 at screening in the presence of a comorbidity of hypertension and/or dyslipidemia
- Must have stable weight, ie, change of \< =5% in the 3 months before screening
- Must agree to utilize a highly effective method of birth control
Exclusion
- An established diagnosis of diabetes mellitus
- Has a history of obesity with a known secondary cause (eg, Cushing's disease/syndrome)
- Has a history of hereditary glucose-galactose malabsorption or primary renal glycosuria
- Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 12 weeks before screening
- Has an Glycated hemoglobin (HBA1c) greater than or equal (\>=) to 65 percent
- An average of 3 seated blood pressure (BP) readings of systolic BP \>= 160 mm Hg and/or Diastolic BP \>= 100 millimeters of mercury at screening
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT02243202
Start Date
September 1 2014
End Date
June 1 2015
Last Update
October 6 2016
Active Locations (17)
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1
Phoenix, Arizona, United States
2
Walnut Creek, California, United States
3
Jacksonville, Florida, United States
4
Meridian, Idaho, United States