Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study (UK 92480)
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ClinicalTrials.gov Identifier: NCT00878943
Expanded Access Status :
No longer available
First Posted : April 9, 2009
Last Update Posted : February 1, 2021
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
In an earlier study, sildenafil citrate administered to patients of PAH led to improvement in pulmonary arterial pressure, cardiac output, quality of life, and other parameters as compared to placebo. This protocol provides mechanism for patients who have clinical deterioration on other PAH approved therapies to have access to sildenafil prior to marketing authorization in India.
A Local, Multi-centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study In India Or Ongoing In A1481269 Study Who Continue To Receive Benefit From Sildenafil Therapy.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subject who complete the A1481244 study and require Sildenafil (Revatio TM) 20 mg TID therapy.
All women of childbearing potential must use adequate contraception throughout the study and four weeks after completion of the study
Pregnant or lactating women
Participation in other studies during study participation
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation