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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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Arizona
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United States of America
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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
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Armentieres
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France
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Lorient Cedex
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France
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Paris Cedex 18
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France
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Poitiers Cedex
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France
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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
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Herts
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United Kingdom
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Wiltshire
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United Kingdom
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Bath
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United Kingdom
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Luton
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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/show/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/show/NCT00396448