Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy and Safety.

NCT00396448 | Terminated Phase 3 DMC

• 1 other identifier: A5351019
• Study Type: interventional
• Target: 1,253
• Locations: 11 countries
• Sites: 61

Brief Summary

The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in body weight and proportion of subjects with 5% weight loss

  1 year

Secondary Outcomes (1)

• Waist circumference, blood lipids and glucose, prevalence of metabolic syndrome, patient reported outcomes, population PK

  1-2 years

Study Arms (3)

CP-945,598 Treatment B

EXPERIMENTAL

Drug: CP-945,598 Treatment B

CP-945,598 Treatment A

EXPERIMENTAL

Drug: CP-945,598 Treatment A

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CP-945,598 Treatment B DRUG

Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.

CP-945,598 Treatment B

CP-945,598 Treatment A DRUG

Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.

CP-945,598 Treatment A

Placebo DRUG

Subjects receive placebo plus dietary, physical activity, and behavioral counseling.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obese adults with a body mass index \> or = 30 kg/m ; \> or = 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia

You may not qualify if:

• Pregnancy
• Diabetes
• Adults with serious or unstable current or past medical conditions

Sponsors & Collaborators

• Pfizer: lead

Study Sites (61)

Pfizer Investigational Site

Peoria, Arizona, 85381, United States

Location

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Newport Beach, California, 92660-2452, United States

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Miami, Florida, 33143, United States

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Springfield, Illinois, 62704, United States

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Overland Park, Kansas, 66202, United States

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Louisville, Kentucky, 40217, United States

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Farmington Hills, Michigan, 48336, United States

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Cary, North Carolina, 27518, United States

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Raleigh, North Carolina, 27609, United States

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Wilmington, North Carolina, 28401, United States

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Winston-Salem, North Carolina, 27103, United States

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Portland, Oregon, 97210, United States

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Anderson, South Carolina, 29621, United States

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Johnson City, Tennessee, 37601, United States

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Bountiful, Utah, 84010, United States

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Capital Federal, Buenos Aires, 1428, Argentina

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Ramos Mejía, Buenos Aires, 1704, Argentina

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Córdoba, Córdoba Province, X5000IUG, Argentina

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Villa Carlos Paz, Córdoba Province, X5152HQC, Argentina

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Buenos Aires, C1437JCP, Argentina

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Capital Federal, C1181ACH, Argentina

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Caringbah, New South Wales, 2229, Australia

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Miranda, New South Wales, 2228, Australia

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Wollongong, New South Wales, 2500, Australia

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Caboolture, Queensland, 4510, Australia

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Kippa-Ring, Queensland, 4020, Australia

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Clayton, Victoria, 3168, Australia

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Heidelberg, Victoria, 3081, Australia

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Santiago, RM, 7560356, Chile

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Santiago, RM, 7600746, Chile

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Armentières, 59427, France

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Lorient, 56322, France

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Paris, 75877, France

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Poitiers, 86021, France

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Rennes, 35033, France

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Strasbourg, 67098, France

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Berlin, 13125, Germany

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Frankfurt am Main, 60316, Germany

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Hamburg, 20253, Germany

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Leipzig, 04109, Germany

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Mannheim, 68163, Germany

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München, 81675, Germany

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San Luis Potosí City, San Luis Potosí, 78200, Mexico

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Seoul, 100-032, South Korea

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Seoul, 133-792, South Korea

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Seoul, 137-041, South Korea

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Seoul, 138-736, South Korea

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Barcelona, Barcelona, 08036, Spain

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Santiago de Compostela, La Coruña, 15706, Spain

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Madrid, Madrid, 28007, Spain

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Madrid, Madrid, 28040, Spain

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Valencia, Valencia, 46009, Spain

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Gothenburg, 413 45, Sweden

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Stockholm, 141 86, Sweden

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Uppsala, 751 25, Sweden

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Watford, Herts, WD25 0EA, United Kingdom

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Warminster, Wiltshire, BA12 9AA, United Kingdom

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Bath, BA1 3NG, United Kingdom

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Bath, BA2 4BY, United Kingdom

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Luton, LU4 0DZ, United Kingdom

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Northwood, Middlesex, HA6 2RN, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2006
• First Posted: November 7, 2006
• Study Start: February 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: November 7, 2012

Record last verified: 2012-11

Locations

FR (6); ES (5); AR (6); CL (2); GB (6); AU (7); KR (4); ME (1); US (15); SE (3); DE (6)