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

Condition	Intervention	Phase
Obesity	Drug: CP-945,598  Drug: sibutramine	Phase II Phase III

Further Study Details: 

Primary Outcomes: Determine the effect of various doses of CP 945,598 on body weight in obese subjects after 24 weeks of dosing
Secondary Outcomes: -Evaluate the safety and tolerability of CP 945,598 in a 26 week outpatient setting;; -Explore the effect of CP 945,598 on: waist circumference, PD measurements of selected biochemical variables related to energy deficit and weight loss includ
Expected Total Enrollment:  250

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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

Florida
      Pfizer Investigational Site, Orlando,  Florida,  32809,  United States
      Pfizer Investigational Site, Clearwater,  Florida,  33761,  United States
      Pfizer Investigational Site, Kissimmee,  Florida,  34741,  United States
Kentucky
      Pfizer Investigational Site, Louisville,  Kentucky,  40213,  United States
      Pfizer Investigational Site, Lexington,  Kentucky,  40509,  United States
Louisiana
      Pfizer Investigational Site, Baton Rouge,  Louisiana,  70808,  United States
Massachusetts
      Pfizer Investigational Site, Milford,  Massachusetts,  01757,  United States
New York
      Pfizer Investigational Site, New York,  New York,  10021,  United States
North Carolina
      Pfizer Investigational Site, Charlotte,  North Carolina,  28211,  United States
Tennessee
      Pfizer Investigational Site, Nashville,  Tennessee,  37203,  United States
Texas
      Pfizer Investigational Site, Dallas,  Texas,  75231,  United States
      Pfizer Investigational Site, Dallas,  Texas,  75247,  United States
      Pfizer Investigational Site, San Antonio,  Texas,  78229,  United States
Washington
      Pfizer Investigational Site, Tacoma,  Washington,  98403,  United States

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A5351013
Last Updated:  August 23, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00134199
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13