| August 22, 2005 |
| August 11, 2009 |
| March 2005 |
| |
| Determine the effect of various doses of CP 945,598 on body weight in obese subjects after 24 weeks of dosing |
| Same as current |
| Complete list of historical versions of study NCT00134199 on ClinicalTrials.gov Archive Site |
| 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 |
- -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
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| |
| A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese Subjects |
| A 6-Month, Randomized, Double-Blind, Placebo And Positive-Controlled Phase 2b Study To Evaluate The Effect Of Various Doses Of CP-945,598 On Weight Loss In Obese Subjects |
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
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| |
| Phase II, Phase III |
| Interventional |
| Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Obesity |
- Drug: CP-945,598
- Drug: sibutramine
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| |
| |
| |
| Completed |
| 282 |
| November 2005 |
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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
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| Both |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00134199 |
|
| A5351013 |
| Pfizer |
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| April 2006 |