A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese Subjects
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: CP-945,598 (Drug); sibutramine (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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, 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
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Determine the effect of various doses of CP 945,598 on body weight in obese subjects after 24 weeks of dosing
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): 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
Locations and Contacts
Pfizer Investigational Site, Orlando, Florida 32809, United States
Pfizer Investigational Site, Clearwater, Florida 33761, United States
Pfizer Investigational Site, Kissimmee, Florida 34741, United States
Pfizer Investigational Site, Louisville, Kentucky 40213, United States
Pfizer Investigational Site, Lexington, Kentucky 40509, United States
Pfizer Investigational Site, Baton Rouge, Louisiana 70808, United States
Pfizer Investigational Site, Milford, Massachusetts 01757, United States
Pfizer Investigational Site, New York, New York 10021, United States
Pfizer Investigational Site, Charlotte, North Carolina 28211, United States
Pfizer Investigational Site, Nashville, Tennessee 37203, United States
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
Pfizer Investigational Site, Tacoma, Washington 98403, United States
Pfizer Investigational Site, Tacoma, Washington 98418, United States
Additional Information
Starting date: March 2005
Ending date: November 2005
Last updated: July 24, 2006
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