Clinical trial NCT00396448: Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy 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: 2006-11-07
Enrollment: 1253
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/m ; \> or = 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: Change in body weight and proportion of subjects with 5% weight loss
timeFrame: 1 year
Secondary outcomes:
measure: Waist circumference, blood lipids and glucose, prevalence of metabolic syndrome, patient reported outcomes, population PK
timeFrame: 1-2 years
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Farmington Hills
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Cary
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Anderson
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Johnson City
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Bountiful
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Capital Federal
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Ramos Mejia
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Villa Carlos Paz
country: Argentina
facility: Pfizer Investigational Site
state: Cordoba
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Capital Federal
country: Argentina
facility: Pfizer Investigational Site
city: Cordoba
country: Argentina
facility: Pfizer Investigational Site
city: Caringbah
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Miranda
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Wollongong
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Caboolture
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Kippa Ring
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Clayton
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Heidelberg
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Armentieres
country: France
facility: Pfizer Investigational Site
city: Lorient Cedex
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 18
country: France
facility: Pfizer Investigational Site
city: Poitiers Cedex
country: France
facility: Pfizer Investigational Site
city: Rennes Cedex 9
country: France
facility: Pfizer Investigational Site
city: Strasbourg Cedex
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt am Main
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Mannheim
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: San Luis Potosi
country: Mexico
facility: Pfizer Investigational Site
state: SLP
city: Santiago de Compostela
country: Spain
facility: Pfizer Investigational Site
state: La Coruña
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
facility: Pfizer Investigational Site
city: Watford
country: United Kingdom
facility: Pfizer Investigational Site
state: Herts
city: Warminster
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
city: Bath
country: United Kingdom
facility: Pfizer Investigational Site
city: Bath
country: United Kingdom
facility: Pfizer Investigational Site
city: Luton
country: United Kingdom
facility: Pfizer Investigational Site
city: Northwood, Middlesex
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: