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

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Pfizer

Status and phase

Terminated
Phase 3

Conditions

Obesity

Treatments

Drug: CP-945,598 Treatment B
Drug: CP-945,598 Treatment A
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00396448
A5351019

Details and patient eligibility

About

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

Full 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.

Enrollment

1,253 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,253 participants in 3 patient groups, including a placebo group

CP-945,598 Treatment B
Experimental group
Treatment:
Drug: CP-945,598 Treatment B
CP-945,598 Treatment A
Experimental group
Treatment:
Drug: CP-945,598 Treatment A
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

61

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Data sourced from clinicaltrials.gov

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