A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese Subjects

Completed · Phase 2/Phase 3

Conditions studied: Obesity

In brief

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, ghrelin, adiponectin, PAI 1, TNF-α and hsCRP * the relationship between the concentration of the drug on the blood and the above parameters * physical and psychosocial functioning, weight related symptoms, treatment satisfaction, appetite/hunger/satiety/craving and mood, anxiety, anhedonia and depression

Key facts

Study ID

NCT00134199

Run by

Pfizer

People needed

282

Starts

2005-03-01

Expected to finish

2005-11-01

Last updated by the study team

2009-08-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)];

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Clearwater, Florida, United States
• Pfizer Investigational Site — Kissimmee, Florida, United States
• Pfizer Investigational Site — Orlando, Florida, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — Baton Rouge, Louisiana, United States
• Pfizer Investigational Site — Milford, Massachusetts, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Charlotte, North Carolina, United States
• Pfizer Investigational Site — Nashville, Tennessee, United States
• Pfizer Investigational Site — Dallas, Texas, United States
• Pfizer Investigational Site — Dallas, Texas, United States
• Pfizer Investigational Site — San Antonio, Texas, United States
• Pfizer Investigational Site — Tacoma, Washington, United States
• Pfizer Investigational Site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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