Study Stopped
See termination reason in detailed description.
A 14-Month Study On The Effects Of CP-945,598 For The Prevention Of Weight Regain In Obese Patients
A 14-Month, Randomized, Double-Blind,Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety of CP-945,598 In Prevention Of Weight Regain In Obese Subjects
1 other identifier
interventional
699
5 countries
26
Brief Summary
The purpose of this study is to determine if CP-945,598 is effective in the prevention of weight regain in obese subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Jan 2008
Shorter than P25 for phase_3 obesity
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2007
CompletedFirst Posted
Study publicly available on registry
June 6, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedNovember 7, 2012
November 1, 2012
1 year
June 4, 2007
November 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Percent weight regained during the 12 month treatment period after a prior weight loss on the low calorie diet (8 weeks).
14 months
Secondary Outcomes (5)
To explore the effect of CP 954, 598 on: Waist circumference
14 months
To evaluate the safety and tolerability of CP 945,598 urine and blood tests
14 months
To explore the effect of CP 954, 598 on: Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, adiponectin
14 months
To explore the effect of CP 954, 598 on: Patient reported outcomes: Power of Food Scale and Three factor Eating Scale
14 months
To explore the effect of CP 954, 598 GAD 7 and PHQ 9 self report questionnaires. and C-SSRS semi structured interview
14 months
Study Arms (3)
Placebo
PLACEBO COMPARATORNon-pharmacological weight loss program (NPP)
OTHERLow Calorie Diet
OTHERInterventions
Nutrition counseling, exercise monitoring and behavioral management will occur for all arms during the NPP.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (26)
Pfizer Investigational Site
La Jolla, California, 92037, United States
Pfizer Investigational Site
Denver, Colorado, 80220, United States
Pfizer Investigational Site
Baton Rouge, Louisiana, 70808, United States
Pfizer Investigational Site
Boston, Massachusetts, 02118, United States
Pfizer Investigational Site
St Louis, Missouri, 63110, United States
Pfizer Investigational Site
New York, New York, 10021-7903, United States
Pfizer Investigational Site
Durham, North Carolina, 27710, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104, United States
Pfizer Investigational Site
Seattle, Washington, 98108, United States
Pfizer Investigational Site
Camperdown, New South Wales, 2050, Australia
Pfizer Investigational Site
Kippa-Ring, Queensland, 4021, Australia
Pfizer Investigational Site
Adelaide, South Australia, 5000, Australia
Pfizer Investigational Site
Bedford Park, South Australia, 5042, Australia
Pfizer Investigational Site
Heidelberg, Victoria, 3081, Australia
Pfizer Investigational Site
Aarhus, 8000, Denmark
Pfizer Investigational Site
Frederiksberg C, 1958, Denmark
Pfizer Investigational Site
Gentofte Municipality, 2820, Denmark
Pfizer Investigational Site
Roskilde, 4000, Denmark
Pfizer Investigational Site
Almere Stad, 1311 RL, Netherlands
Pfizer Investigational Site
Amsterdam, 1081 HV, Netherlands
Pfizer Investigational Site
Amsterdam, 1105 AZ, Netherlands
Pfizer Investigational Site
Hilversum, 1213 RH, Netherlands
Pfizer Investigational Site
Cape Town, Gauteng, 7708, South Africa
Pfizer Investigational Site
Johannesburg, Gauteng, 7500, South Africa
Pfizer Investigational Site
Pretoria, Gauteng, 0157, South Africa
Pfizer Investigational Site
Pretoria, South Africa
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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
June 4, 2007
First Posted
June 6, 2007
Study Start
January 1, 2008
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
November 7, 2012
Record last verified: 2012-11