Status:
COMPLETED
A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese Subjects
Lead Sponsor:
Pfizer
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
To evaluate the effect of 6-month administration of CP-945,598 on: * weight loss and waist circumference, * blood pressure, cholesterol, glucose * other biochemical variables like insulin, leptin, gh...
Eligibility Criteria
Inclusion
- Male and/or female subjects without clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12 lead ECG and clinical laboratory tests
- Body Mass Index (BMI) ³30 and \<40 kg/m2, for subjects with no additional
- co morbidities; BMI ³27 kg/m2 and \<40 kg/m2, for subjects with co morbidities \[history of essential hypertension and/or dyslipidemia defined as high LDL (³160 mg/dL) or high total cholesterol (³240 mg/dL)\];
Exclusion
- Subjects with resting sitting systolic blood pressure of 140 mmHg or greater or diastolic blood pressure of 90 mmHg or greater.
- Subjects with type 2 diabetes or fasting blood glucose concentration ³126 mg/dL;
- Subjects with a history of eating disorders like anorexia nervosa or bulimia nervosa
- Subjects on prescription and non-prescription appetite or weight modifying drugs
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT00134199
Start Date
March 1 2005
End Date
November 1 2005
Last Update
August 12 2009
Active Locations (15)
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1
Pfizer Investigational Site
Clearwater, Florida, United States, 33761
2
Pfizer Investigational Site
Kissimmee, Florida, United States, 34741
3
Pfizer Investigational Site
Orlando, Florida, United States, 32809
4
Pfizer Investigational Site
Lexington, Kentucky, United States, 40509