Overview

Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil

Status:
Terminated

Trial end date:
2011-03-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Endothelin Receptor Antagonists
Sildenafil Citrate
Sitaxsentan

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- 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.