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

TerminadoFase 3ClinicalTrials.gov

ID: NCT00396448Tipo: INTERVENTIONALInicio: 1 de feb de 2007Fin estimado: 1 de feb de 2009

Endocrinología

Traducción no disponible, mostrando original

Resumen

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

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

Pregnancy
Diabetes
Adults with serious or unstable current or past medical conditions

Intervenciones

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.

Ubicaciones

Pfizer Investigational Site

Capital Federal, Buenos Aires, Argentina

Pfizer Investigational Site

Ramos Mejía, Buenos Aires, Argentina

Pfizer Investigational Site

Córdoba, Córdoba Province, Argentina

Pfizer Investigational Site

Villa Carlos Paz, Córdoba Province, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Capital Federal, Argentina

Patrocinadores

PrincipalPfizer

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