A Long-Term Study To Examine The Effects Of CP-945,598 On Weight Loss And Safety

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00375401
First received: September 11, 2006
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults


Condition Intervention Phase
Obesity
Drug: CP-945,598 Treatment A
Drug: CP-945,598 Treatment B
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Proportion of subjects with 5% weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure, blood lipids and glucose, waist circumference, quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 2536
Study Start Date: October 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CP-945,598 Treatment A Drug: CP-945,598 Treatment A
Arm includes CP-945,598 Treatment A plus Dietary, Physical Activity, and Weight Loss Counseling
Experimental: CP-945,598 Treatment B Drug: CP-945,598 Treatment B
Arm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling
Placebo Comparator: Placebo Drug: Placebo
Arm includes Placebo plus Dietary, Physical Activity, and Weight Loss Counseling

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obese adults with a body mass index > or = 30 kg/m2; > or = to 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375401

  Show 82 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00375401     History of Changes
Other Study ID Numbers: A5351025
Study First Received: September 11, 2006
Last Updated: November 5, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 30, 2014