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Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study

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.

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00878943
Acronym
UK 92480
Enrollment
Unknown
Registered
2009-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Keywords

Open label access, sildenafil, pulmonary arterial hypertension

Brief summary

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.

Interventions

DRUGSildenafil citrate

20 mg tablet to be taken thrice daily for 1 year

Sponsors

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026