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

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ClinicalTrials.gov Identifier: NCT00375401
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : September 13, 2006
Last Update Posted : November 7, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2536 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Proportion of subjects with 5% weight loss [ Time Frame: 1 year ]
  2. Change in body weight [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Blood pressure, blood lipids and glucose, waist circumference, quality of life [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375401


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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00375401     History of Changes
Other Study ID Numbers: A5351025
First Posted: September 13, 2006    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012