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

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

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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