Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00483171




Registration number
NCT00483171
Ethics application status
Date submitted
4/06/2007
Date registered
6/06/2007
Date last updated
7/11/2012

Titles & IDs
Public title
A 14-Month Study On The Effects Of CP-945,598 For The Prevention Of Weight Regain In Obese Patients
Scientific 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
Secondary ID [1] 0 0
A5351028
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CP-945,598
BEHAVIORAL - Non-pharmacological weight loss program (NPP)
BEHAVIORAL - Low Calorie Diet

Placebo comparator: Placebo -

Other: Non-pharmacological weight loss program (NPP) -

Other: Low Calorie Diet -


Treatment: Drugs: 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.

BEHAVIORAL: Low Calorie Diet
Low calorie diet
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent weight regained during the 12 month treatment period after a prior weight loss on the low calorie diet (8 weeks).
Timepoint [1] 0 0
14 months
Secondary outcome [1] 0 0
To explore the effect of CP 954, 598 on: Waist circumference
Timepoint [1] 0 0
14 months
Secondary outcome [2] 0 0
To evaluate the safety and tolerability of CP 945,598 urine and blood tests
Timepoint [2] 0 0
14 months
Secondary outcome [3] 0 0
To explore the effect of CP 954, 598 on: Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, adiponectin
Timepoint [3] 0 0
14 months
Secondary outcome [4] 0 0
To explore the effect of CP 954, 598 on: Patient reported outcomes: Power of Food Scale and Three factor Eating Scale
Timepoint [4] 0 0
14 months
Secondary outcome [5] 0 0
To explore the effect of CP 954, 598 GAD 7 and PHQ 9 self report questionnaires. and C-SSRS semi structured interview
Timepoint [5] 0 0
14 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2009
Sample size
Target
Accrual to date
Final
699
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Kippa Ring
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Bedford Park
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Denmark
State/province [10] 0 0
Aarhus
Country [11] 0 0
Denmark
State/province [11] 0 0
Frederiksberg C
Country [12] 0 0
Denmark
State/province [12] 0 0
Gentofte
Country [13] 0 0
Denmark
State/province [13] 0 0
Roskilde
Country [14] 0 0
Netherlands
State/province [14] 0 0
Almere
Country [15] 0 0
Netherlands
State/province [15] 0 0
Amsterdam
Country [16] 0 0
Netherlands
State/province [16] 0 0
Hilversum
Country [17] 0 0
South Africa
State/province [17] 0 0
Gauteng
Country [18] 0 0
South Africa
State/province [18] 0 0
Pretoria

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00483171