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Completed

NCT Number: NCT00134199

A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Pfizer Investigational Site, Clearwater, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP-945,598

Drug

sibutramine

Drug

Primary outcomes

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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2005
First posted
Aug 24, 2005
Registry last updated
Aug 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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