MedDataX Logo

A 14-Month Study On The Effects Of CP-945,598 For The Prevention Of Weight Regain In Obese Patients

NCT ID: NCT00483171

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

699 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-01-31

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 determine if CP-945,598 is effective in the prevention of weight regain in obese subjects.

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.

Placebo

Group Type PLACEBO_COMPARATOR

CP-945,598

Intervention Type DRUG

CP-945,598

Non-pharmacological weight loss program (NPP)

Group Type OTHER

Non-pharmacological weight loss program (NPP)

Intervention Type BEHAVIORAL

Nutrition counseling, exercise monitoring and behavioral management will occur for all arms during the NPP.

Low Calorie Diet

Group Type OTHER

Low Calorie Diet

Intervention Type BEHAVIORAL

Low calorie diet

Interventions

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

CP-945,598

CP-945,598

Intervention Type DRUG

Non-pharmacological weight loss program (NPP)

Nutrition counseling, exercise monitoring and behavioral management will occur for all arms during the NPP.

Intervention Type BEHAVIORAL

Low Calorie Diet

Low calorie diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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

Inclusion Criteria

* Subject must be overweight (BMI) \>/=30 kg/m2, for subjects without co morbidities; \>/=27 kg/m2 for subjects with co morbidities
* Subjects who are willing and able to comply with 8 week Low Calorie Diet, scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria

* Participation in a formal weight loss program or significant weight loss (fluctuation \>5% of total body weight) in the past 3 months.
* Subjects with serious medical or psychiatric 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

La Jolla, California, United States

Site Status

Pfizer Investigational Site

Denver, Colorado, United States

Site Status

Pfizer Investigational Site

Baton Rouge, Louisiana, United States

Site Status

Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

St Louis, Missouri, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Pfizer Investigational Site

Durham, North Carolina, United States

Site Status

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Seattle, Washington, United States

Site Status

Pfizer Investigational Site

Camperdown, New South Wales, Australia

Site Status

Pfizer Investigational Site

Kippa-Ring, Queensland, Australia

Site Status

Pfizer Investigational Site

Adelaide, South Australia, Australia

Site Status

Pfizer Investigational Site

Bedford Park, South Australia, Australia

Site Status

Pfizer Investigational Site

Heidelberg, Victoria, Australia

Site Status

Pfizer Investigational Site

Aarhus, , Denmark

Site Status

Pfizer Investigational Site

Frederiksberg C, , Denmark

Site Status

Pfizer Investigational Site

Gentofte Municipality, , Denmark

Site Status

Pfizer Investigational Site

Roskilde, , Denmark

Site Status

Pfizer Investigational Site

Almere Stad, , Netherlands

Site Status

Pfizer Investigational Site

Amsterdam, , Netherlands

Site Status

Pfizer Investigational Site

Amsterdam, , Netherlands

Site Status

Pfizer Investigational Site

Hilversum, , Netherlands

Site Status

Pfizer Investigational Site

Cape Town, Gauteng, South Africa

Site Status

Pfizer Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Pfizer Investigational Site

Pretoria, Gauteng, South Africa

Site Status

Pfizer Investigational Site

Pretoria, , South Africa

Site Status

Countries

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

United States Australia Denmark Netherlands South Africa

Related Links

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

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5351028&StudyName=A%2014-Month%20Study%20On%20The%20Effects%20Of%20CP-945%2C598%20For%20The%20Prevention%20Of%20Weight%20Regain%20In%20Obese%20Patients

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

Other Identifiers

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

A5351028

Identifier Type: -

Identifier Source: org_study_id