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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
This study has been completed.
Study NCT00134199   Information provided by Pfizer
First Received: August 22, 2005   Last Updated: August 11, 2009   History of Changes

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
 
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
 
Phase II, Phase III
Interventional
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Obesity
  • Drug: CP-945,598
  • Drug: sibutramine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
282
November 2005
 

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
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP