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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00483171

Purpose

The purpose of this study is to determine if CP-945,598 is effective in the prevention of weight regain in obese subjects.

Condition	Intervention	Phase
Obesity	Drug: CP-945,598 Behavioral: Non-pharmacological weight loss program (NPP) Behavioral: Low Calorie Diet	Phase III

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Percent weight regained during the 12 month treatment period after a prior weight loss on the low calorie diet (8 weeks). [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To explore the effect of CP 954, 598 on: Waist circumference [ Time Frame: 14 months ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of CP 945,598 urine and blood tests [ Time Frame: 14 months ] [ Designated as safety issue: No ]
To explore the effect of CP 954, 598 on: Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, adiponectin [ Time Frame: 14 months ] [ Designated as safety issue: No ]
To explore the effect of CP 954, 598 on: Patient reported outcomes: Power of Food Scale and Three factor Eating Scale [ Time Frame: 14 months ] [ Designated as safety issue: No ]
To explore the effect of CP 954, 598 GAD 7 and PHQ 9 self report questionnaires. and C-SSRS semi structured interview [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	850
Study Start Date:	January 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: CP-945,598 CP-945,598
Non-pharmacological weight loss program (NPP)	Behavioral: Non-pharmacological weight loss program (NPP) Nutrition counseling, exercise monitoring and behavioral management will occur for all arms during the NPP.
Low Calorie Diet	Behavioral: Low Calorie Diet Low calorie diet

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483171

Show 26 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5351028
Study First Received:	June 4, 2007
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00483171
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 14, 2009