A Long-Term Study To Examine The Effects Of CP-945,598 On Weight Loss And Safety

NCT00375401 | Terminated Phase 3 DMC

• 1 other identifier: A5351025
• Study Type: interventional
• Target: 2,536
• Locations: 2 countries
• Sites: 82

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 (2)

• Proportion of subjects with 5% weight loss

  1 year

• Change in body weight

  1 year

Secondary Outcomes (1)

• Blood pressure, blood lipids and glucose, waist circumference, quality of life

  2 years

Study Arms (3)

CP-945,598 Treatment A

EXPERIMENTAL

Drug: CP-945,598 Treatment A

CP-945,598 Treatment B

EXPERIMENTAL

Drug: CP-945,598 Treatment B

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CP-945,598 Treatment A DRUG

Arm includes CP-945,598 Treatment A plus Dietary, Physical Activity, and Weight Loss Counseling

CP-945,598 Treatment A

CP-945,598 Treatment B DRUG

Arm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling

CP-945,598 Treatment B

Placebo DRUG

Arm includes Placebo plus Dietary, Physical Activity, and Weight Loss 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/m2; \> or = to 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 (82)

Pfizer Investigational Site

Fairhope, Alabama, 36532, United States

Location

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Huntsville, Alabama, 35801, United States

Location

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Mobile, Alabama, 36608, United States

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La Jolla, California, 92037, United States

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Oakland, California, 94609-3223, United States

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San Diego, California, 92128, United States

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San Diego, California, 92130, United States

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Santa Ana, California, 92705, United States

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Walnut Creek, California, 94598, United States

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Longmont, Colorado, 80501, United States

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Orlando, Florida, 32809, United States

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Atlanta, Georgia, 30342, United States

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Honolulu, Hawaii, 96814, United States

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Chicago, Illinois, 60610, United States

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Gurnee, Illinois, 60031, United States

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Indianapolis, Indiana, 46260, United States

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Wichita, Kansas, 67207, United States

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Lexington, Kentucky, 40509, United States

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Louisville, Kentucky, 40213, United States

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Louisville, Kentucky, 40223, United States

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Madisonville, Kentucky, 42431, United States

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Baton Rouge, Louisiana, 70808, United States

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Baton Rouge, Louisiana, 70809, United States

Location

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Scarborough, Maine, 04074, United States

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Baltimore, Maryland, 21201, United States

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Baltimore, Maryland, 21204, United States

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Boston, Massachusetts, 02114, United States

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Milford, Massachusetts, 01757, United States

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North Dartmouth, Massachusetts, 02747, United States

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Troy, Michigan, 48098, United States

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Chaska, Minnesota, 55318, United States

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Edina, Minnesota, 55435, United States

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Minneapolis, Minnesota, 55415, United States

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Waconia, Minnesota, 55387, United States

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Kansas City, Missouri, 64114, United States

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Hamilton, New Jersey, 08690, United States

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Albuquerque, New Mexico, 87108, United States

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Endwell, New York, 13760, United States

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Kingston, New York, 12401, United States

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Manlius, New York, 13104, United States

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New York, New York, 10021-7903, United States

Location

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Rochester, New York, 14609, United States

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Burlington, North Carolina, 27215, United States

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Charlotte, North Carolina, 28211, United States

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Charlotte, North Carolina, 28277, United States

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Fargo, North Dakota, 58103, United States

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Akron, Ohio, 44311, United States

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Medford, Oregon, 97504, United States

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Beaver, Pennsylvania, 15009, United States

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Philadelphia, Pennsylvania, 19104, United States

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Cumberland, Rhode Island, 02864, United States

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Pawtucket, Rhode Island, 02860, United States

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Greer, South Carolina, 29651, United States

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Mt. Pleasant, South Carolina, 29464, United States

Location

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Bristol, Tennessee, 37620, United States

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Kingsport, Tennessee, 37660, United States

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Knoxville, Tennessee, 37920, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78705, United States

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Beaumont, Texas, 77701, United States

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Dallas, Texas, 75246, United States

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Dallas, Texas, 75390-8858, United States

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Fort Worth, Texas, 76135, United States

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Fort Worth, Texas, 76137, United States

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Lake Jackson, Texas, 77566, United States

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San Antonio, Texas, 78229, United States

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Charlottesville, Virginia, 22911, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23294, United States

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Olympia, Washington, 98502, United States

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Renton, Washington, 98057, United States

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Morgantown, West Virginia, 26506-9136, United States

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Milwaukee, Wisconsin, 53209, United States

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Oregon, Wisconsin, 53575, United States

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Calgary, Alberta, T2E 7C5, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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Hamilton, Ontario, L8L 2X2, Canada

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Oakville, Ontario, L6H 3P1, Canada

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Toronto, Ontario, M4R 2G4, Canada

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Charlottetown, Prince Edward Island, C1E 1J7, Canada

Location

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L'Ancienne-Lorette, Quebec, G2E 2X1, Canada

Location

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Montreal, Quebec, H2W 1R7, Canada

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: September 11, 2006
• First Posted: September 13, 2006
• Study Start: October 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: November 7, 2012

Record last verified: 2012-11

Locations

US (74); CA (8)