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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00396448




Registration number
NCT00396448
Ethics application status
Date submitted
6/11/2006
Date registered
7/11/2006
Date last updated
7/11/2012

Titles & IDs
Public title
Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy and Safety.
Scientific title
A 2-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety Of CP-945,598 In The Treatment Of Obese Subjects
Secondary ID [1] 0 0
A5351019
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 Treatment B
Treatment: Drugs - CP-945,598 Treatment A
Treatment: Drugs - Placebo

Experimental: CP-945,598 Treatment B -

Experimental: CP-945,598 Treatment A -

Placebo comparator: Placebo -


Treatment: Drugs: CP-945,598 Treatment B
Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.

Treatment: Drugs: CP-945,598 Treatment A
Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.

Treatment: Drugs: Placebo
Subjects receive placebo plus dietary, physical activity, and behavioral counseling.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in body weight and proportion of subjects with 5% weight loss
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Waist circumference, blood lipids and glucose, prevalence of metabolic syndrome, patient reported outcomes, population PK
Timepoint [1] 0 0
1-2 years

Eligibility
Key inclusion criteria
* Obese adults with a body mass index > or = 30 kg/m ; > or = 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy
* Diabetes
* Adults with serious or unstable current or past medical 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
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2009
Sample size
Target
Accrual to date
Final
1253
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Caringbah
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Miranda
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Wollongong
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Caboolture
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Kippa Ring
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Clayton
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2229 - Caringbah
Recruitment postcode(s) [2] 0 0
2228 - Miranda
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4510 - Caboolture
Recruitment postcode(s) [5] 0 0
4020 - Kippa Ring
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3081 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Michigan
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United States of America
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North Carolina
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United States of America
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Oregon
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Utah
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Capital Federal
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Chile
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RM
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France
State/province [17] 0 0
Armentieres
Country [18] 0 0
France
State/province [18] 0 0
Lorient Cedex
Country [19] 0 0
France
State/province [19] 0 0
Paris Cedex 18
Country [20] 0 0
France
State/province [20] 0 0
Poitiers Cedex
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France
State/province [21] 0 0
Rennes Cedex 9
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France
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Strasbourg Cedex
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Germany
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Berlin
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Germany
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Frankfurt am Main
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Germany
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Hamburg
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Germany
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Leipzig
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Germany
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Mannheim
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Germany
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Muenchen
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Korea, Republic of
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Seoul
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Mexico
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SLP
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Spain
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La Coruña
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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Sweden
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Goteborg
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Sweden
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Stockholm
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Sweden
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Uppsala
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United Kingdom
State/province [38] 0 0
Herts
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Wiltshire
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Bath
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Luton
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Northwood, Middlesex

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults
Trial website
https://clinicaltrials.gov/study/NCT00396448
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00396448