A Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001 (NCT00795639)

TerminadoFase 3ClinicalTrials.gov

ID: NCT00796666Tipo: INTERVENTIONALInicio: 1 de may de 2009Fin estimado: 1 de mar de 2011

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Resumen

As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated the controlled safety/efficacy database of the combination is limited.

Elegibilidad

Edad mínima: 16 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Previously enrolled in B1321001 (NCT00795639) and completed the 12-week study as planned.

Criterios de exclusión

Treated with an investigational drug, other than sitaxsentan sodium in B1321001 (NCT00795639), or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.

Intervenciones

drug

Sitaxsentan

Sitaxsentan = 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day

drug

Sitaxsentan and Sildenafil

Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day

Ubicaciones

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalPfizer

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