Clinical trial NCT00483171: A 14-Month Study On The Effects Of CP-945,598 For The Prevention Of Weight Regain In Obese Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-06
Enrollment: 699
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Percent weight regained during the 12 month treatment period after a prior weight loss on the low calorie diet (8 weeks).
timeFrame: 14 months
Secondary outcomes:
measure: To explore the effect of CP 954, 598 on: Waist circumference
timeFrame: 14 months
measure: To evaluate the safety and tolerability of CP 945,598 urine and blood tests
timeFrame: 14 months
measure: To explore the effect of CP 954, 598 on: Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, adiponectin
timeFrame: 14 months
measure: To explore the effect of CP 954, 598 on: Patient reported outcomes: Power of Food Scale and Three factor Eating Scale
timeFrame: 14 months
measure: To explore the effect of CP 954, 598 GAD 7 and PHQ 9 self report questionnaires. and C-SSRS semi structured interview
timeFrame: 14 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Camperdown
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Kippa Ring
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Bedford Park
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Heidelberg
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Aarhus
country: Denmark
facility: Pfizer Investigational Site
city: Frederiksberg C
country: Denmark
facility: Pfizer Investigational Site
city: Gentofte
country: Denmark
facility: Pfizer Investigational Site
city: Roskilde
country: Denmark
facility: Pfizer Investigational Site
city: Almere
country: Netherlands
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Hilversum
country: Netherlands
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: