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

NCT ID: NCT00396448

Last Updated: 2012-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CP-945,598 Treatment B

Group Type EXPERIMENTAL

CP-945,598 Treatment B

Intervention Type DRUG

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

CP-945,598 Treatment A

Group Type EXPERIMENTAL

CP-945,598 Treatment A

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CP-945,598 Treatment B

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

Intervention Type DRUG

CP-945,598 Treatment A

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Peoria, Arizona, United States

Site Status

Pfizer Investigational Site

Newport Beach, California, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Springfield, Illinois, United States

Site Status

Pfizer Investigational Site

Overland Park, Kansas, United States

Site Status

Pfizer Investigational Site

Louisville, Kentucky, United States

Site Status

Pfizer Investigational Site

Farmington Hills, Michigan, United States

Site Status

Pfizer Investigational Site

Cary, North Carolina, United States

Site Status

Pfizer Investigational Site

Raleigh, North Carolina, United States

Site Status

Pfizer Investigational Site

Wilmington, North Carolina, United States

Site Status

Pfizer Investigational Site

Winston-Salem, North Carolina, United States

Site Status

Pfizer Investigational Site

Portland, Oregon, United States

Site Status

Pfizer Investigational Site

Anderson, South Carolina, United States

Site Status

Pfizer Investigational Site

Johnson City, Tennessee, United States

Site Status

Pfizer Investigational Site

Bountiful, Utah, United States

Site Status

Pfizer Investigational Site

Capital Federal, Buenos Aires, Argentina

Site Status

Pfizer Investigational Site

Ramos Mejía, Buenos Aires, Argentina

Site Status

Pfizer Investigational Site

Córdoba, Córdoba Province, Argentina

Site Status

Pfizer Investigational Site

Villa Carlos Paz, Córdoba Province, Argentina

Site Status

Pfizer Investigational Site

Buenos Aires, , Argentina

Site Status

Pfizer Investigational Site

Capital Federal, , Argentina

Site Status

Pfizer Investigational Site

Caringbah, New South Wales, Australia

Site Status

Pfizer Investigational Site

Miranda, New South Wales, Australia

Site Status

Pfizer Investigational Site

Wollongong, New South Wales, Australia

Site Status

Pfizer Investigational Site

Caboolture, Queensland, Australia

Site Status

Pfizer Investigational Site

Kippa-Ring, Queensland, Australia

Site Status

Pfizer Investigational Site

Clayton, Victoria, Australia

Site Status

Pfizer Investigational Site

Heidelberg, Victoria, Australia

Site Status

Pfizer Investigational Site

Santiago, RM, Chile

Site Status

Pfizer Investigational Site

Santiago, RM, Chile

Site Status

Pfizer Investigational Site

Armentières, , France

Site Status

Pfizer Investigational Site

Lorient, , France

Site Status

Pfizer Investigational Site

Paris, , France

Site Status

Pfizer Investigational Site

Poitiers, , France

Site Status

Pfizer Investigational Site

Rennes, , France

Site Status

Pfizer Investigational Site

Strasbourg, , France

Site Status

Pfizer Investigational Site

Berlin, , Germany

Site Status

Pfizer Investigational Site

Frankfurt am Main, , Germany

Site Status

Pfizer Investigational Site

Hamburg, , Germany

Site Status

Pfizer Investigational Site

Leipzig, , Germany

Site Status

Pfizer Investigational Site

Mannheim, , Germany

Site Status

Pfizer Investigational Site

München, , Germany

Site Status

Pfizer Investigational Site

San Luis Potosí City, San Luis Potosí, Mexico

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Barcelona, Barcelona, Spain

Site Status

Pfizer Investigational Site

Santiago de Compostela, La Coruña, Spain

Site Status

Pfizer Investigational Site

Madrid, Madrid, Spain

Site Status

Pfizer Investigational Site

Madrid, Madrid, Spain

Site Status

Pfizer Investigational Site

Valencia, Valencia, Spain

Site Status

Pfizer Investigational Site

Gothenburg, , Sweden

Site Status

Pfizer Investigational Site

Stockholm, , Sweden

Site Status

Pfizer Investigational Site

Uppsala, , Sweden

Site Status

Pfizer Investigational Site

Watford, Herts, United Kingdom

Site Status

Pfizer Investigational Site

Warminster, Wiltshire, United Kingdom

Site Status

Pfizer Investigational Site

Bath, , United Kingdom

Site Status

Pfizer Investigational Site

Bath, , United Kingdom

Site Status

Pfizer Investigational Site

Luton, , United Kingdom

Site Status

Pfizer Investigational Site

Northwood, Middlesex, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Chile France Germany Mexico South Korea Spain Sweden United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A5351019

Identifier Type: -

Identifier Source: org_study_id