Clinical trial NCT00375401: A Long-Term Study To Examine The Effects Of CP-945,598 On Weight Loss And Safety
Official title: A 2-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety Of CP-945,598 In The Treatment Of Obese Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-13
Enrollment: 2536
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: The CP-945,598 program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of subjects with 5% weight loss
timeFrame: 1 year
measure: Change in body weight
timeFrame: 1 year
Secondary outcomes:
measure: Blood pressure, blood lipids and glucose, waist circumference, quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Oakland
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Ana
country: United States
facility: Pfizer Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Pfizer Investigational Site
state: California
city: Longmont
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Gurnee
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Madisonville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Scarborough
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Milford
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: North Dartmouth
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Troy
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Chaska
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Edina
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Waconia
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Hamilton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Endwell
country: United States
facility: Pfizer Investigational Site
state: New York
city: Kingston
country: United States
facility: Pfizer Investigational Site
state: New York
city: Manlius
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Burlington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Akron
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Medford
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Beaver
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Cumberland
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Pawtucket
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lake Jackson
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Olympia
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Renton
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Morgantown
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Oregon
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Charlottetown
country: Canada
facility: Pfizer Investigational Site
state: Prince Edward Island
city: L'Ancienne-Lorette
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: