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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00483171
• Other study ID #: A5351028
• Status: Terminated
• Phase: Phase 3
• First received: June 4, 2007
• Last updated: November 5, 2012
• Start date: January 2008
• Est. completion date: January 2009

Study information

• Verified date: November 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 699
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• CP-945,598
CP-945,598

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
Low calorie diet

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Adelaide	South Australia
Australia	Pfizer Investigational Site	Bedford Park	South Australia
Australia	Pfizer Investigational Site	Camperdown	New South Wales
Australia	Pfizer Investigational Site	Heidelberg	Victoria
Australia	Pfizer Investigational Site	Kippa Ring	Queensland
Denmark	Pfizer Investigational Site	Aarhus
Denmark	Pfizer Investigational Site	Frederiksberg C
Denmark	Pfizer Investigational Site	Gentofte
Denmark	Pfizer Investigational Site	Roskilde
Netherlands	Pfizer Investigational Site	Almere
Netherlands	Pfizer Investigational Site	Amsterdam
Netherlands	Pfizer Investigational Site	Amsterdam
Netherlands	Pfizer Investigational Site	Hilversum
South Africa	Pfizer Investigational Site	Cape Town	Gauteng
South Africa	Pfizer Investigational Site	Johannesburg	Gauteng
South Africa	Pfizer Investigational Site	Pretoria	Gauteng
South Africa	Pfizer Investigational Site	Pretoria
United States	Pfizer Investigational Site	Baton Rouge	Louisiana
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	La Jolla	California
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Denmark,  Netherlands,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent weight regained during the 12 month treatment period after a prior weight loss on the low calorie diet (8 weeks).		14 months	No
Secondary	To explore the effect of CP 954, 598 on: Waist circumference		14 months	No
Secondary	To evaluate the safety and tolerability of CP 945,598 urine and blood tests		14 months	No
Secondary	To explore the effect of CP 954, 598 on: Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, adiponectin		14 months	No
Secondary	To explore the effect of CP 954, 598 on: Patient reported outcomes: Power of Food Scale and Three factor Eating Scale		14 months	No
Secondary	To explore the effect of CP 954, 598 GAD 7 and PHQ 9 self report questionnaires. and C-SSRS semi structured interview		14 months	No

External Links

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