Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study
UK 92480
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.
1 other identifier
expanded_access
N/A
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2009
CompletedFirst Posted
Study publicly available on registry
April 9, 2009
CompletedFebruary 1, 2021
January 1, 2021
April 8, 2009
January 28, 2021
Conditions
Keywords
Interventions
20 mg tablet to be taken thrice daily for 1 year
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
The Institute of Medical Sciences, CARE Hospital
Hyderabad, Andhra Pradesh, 500 001, India
Mehta Hospital & Cardiopulmonary Care Center
Ahmedabad, Gujarat, 380 054, India
Bankers Heart Institute
Vadodara, Gujarat, 390 015, India
St Johns Medical College Hospital
Bangalore, Karnataka, 560 034, India
Metro Multispeciality Hospital
Noida, Uttar Pradesh, 201301, India
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2009
First Posted
April 9, 2009
Last Updated
February 1, 2021
Record last verified: 2021-01