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NCT00878943 Clinical Trial

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

Pulmonary Arterial Hypertension Clinical Trial

— UK 92480  

Official title:
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.

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT00878943
Other study ID # A1481269
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sildenafil citrate
20 mg tablet to be taken thrice daily for 1 year

Locations
Country Name City State
India Mehta Hospital & Cardiopulmonary Care Center Ahmedabad Gujarat
India St Johns Medical College Hospital Bangalore Karnataka
India The Institute of Medical Sciences, CARE Hospital Hyderabad Andra Pradesh
India Metro Multispeciality Hospital Noida Uttar Pradesh
India Bankers Heart Institute Vadodara Gujarat

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

India, 

See also
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Terminated NCT01953965 - Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. Phase 2
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Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01165047 - Nitric Oxide, GeNO Nitrosyl Delivery System Phase 2
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