A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once-Daily Orally Administered PH-797804 (0.5, 3, 6 And 10 MG) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

CompletadoFase 2ClinicalTrials.gov

ID: NCT00559910Tipo: INTERVENTIONALInicio: 1 de feb de 2008Fin estimado: 1 de dic de 2009

Traducción no disponible, mostrando original

Resumen

PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Male or female subjects between, and including, the ages of 40 and 80 years.
Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease, subjects must have had stable disease for at least 1 month prior to screening.
Subjects must have a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up \> 6 months ago.

Criterios de exclusión

More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalization for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
History or presence of significant cardiovascular disease.
ECG abnormalities.
Significant concomitant clinical disease that could interfere with the conduct, safety or interpretation of results of this study.
Evidence of organ or blood disorders.

Intervenciones

drug

PH-797804

PH-797804 at four dose levels

drug

Placebo

Ubicaciones

Pfizer Investigational Site

La Plata, Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Buenos Aires F.D., Argentina

Pfizer Investigational Site

Buenos Aires, Buenos Aires F.D., Argentina

Pfizer Investigational Site

Ciudad Autonoma de Buenos Aires (caba), Buenos Aires F.D., Argentina

Pfizer Investigational Site

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalPfizer

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