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Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy and Safety.

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Peoria, Arizona, 85381 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Obesity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Pregnancy

- Diabetes

- Adults with serious or unstable current or past medical conditions

NCT00396448
Pfizer
Terminated
Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy and Safety.

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Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy and Safety.
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
The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Obesity
  • Drug: CP-945,598 Treatment B
    Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
  • Drug: CP-945,598 Treatment A
    Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
  • Drug: Placebo
    Subjects receive placebo plus dietary, physical activity, and behavioral counseling.
  • Experimental: CP-945,598 Treatment B
    Intervention: Drug: CP-945,598 Treatment B
  • Experimental: CP-945,598 Treatment A
    Intervention: Drug: CP-945,598 Treatment A
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1253
February 2009
February 2009   (Final data collection date for primary outcome measure)

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

Exclusion Criteria:

  • Pregnancy
  • Diabetes
  • Adults with serious or unstable current or past medical conditions
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Chile,   France,   Germany,   Korea, Republic of,   Mexico,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT00396448
A5351019
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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