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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00134199

Purpose

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-Î± 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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

Drug Information available for: Sibutramine Sibutramine hydrochloride monohydrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Determine the effect of various doses of CP 945,598 on body weight in obese subjects after 24 weeks of dosing

Secondary Outcome Measures:

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

Enrollment:	282
Study Start Date:	March 2005
Study Completion Date:	November 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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) Â³30 and <40 kg/m2, for subjects with no additional
co morbidities; BMI Â³27 kg/m2 and <40 kg/m2, for subjects with co morbidities [history of essential hypertension and/or dyslipidemia defined as high LDL (Â³160 mg/dL) or high total cholesterol (Â³240 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 Â³126 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134199

Locations

United States, Florida
Pfizer Investigational Site
Clearwater, Florida, United States, 33761
Pfizer Investigational Site
Kissimmee, Florida, United States, 34741
Pfizer Investigational Site
Orlando, Florida, United States, 32809
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40509
Pfizer Investigational Site
Louisville, Kentucky, United States, 40213
United States, Louisiana
Pfizer Investigational Site
Baton Rouge, Louisiana, United States, 70808
United States, Massachusetts
Pfizer Investigational Site
Milford, Massachusetts, United States, 01757
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28211
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75231
Pfizer Investigational Site
Dallas, Texas, United States, 75247
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Washington
Pfizer Investigational Site
Tacoma, Washington, United States, 98403
Pfizer Investigational Site
Tacoma, Washington, United States, 98418

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00134199 History of Changes
Other Study ID Numbers:	A5351013
Study First Received:	August 22, 2005
Last Updated:	August 11, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

Sibutramine
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012