UK 92480: Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: No longer available
• CT.gov ID: NCT00878943
• Collaborator: (none)
• Locations: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension	Drug: Sildenafil citrate

Study Design

• Study Type: Expanded Access
• 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.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Institute of Medical Sciences, CARE Hospital	Hyderabad	Andra Pradesh	India	500 001
2	Mehta Hospital & Cardiopulmonary Care Center	Ahmedabad	Gujarat	India	380 054
3	Bankers Heart Institute	Vadodara	Gujarat	India	390 015
4	St Johns Medical College Hospital	Bangalore	Karnataka	India	560 034
5	Metro Multispeciality Hospital	Noida	Uttar Pradesh	India	201301

Sponsors and Collaborators

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

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00878943
• Other Study ID Numbers: A1481269
• First Posted: Apr 9, 2009
• Last Update Posted: Feb 1, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: Open label access; sildenafil; pulmonary arterial hypertension
• Additional relevant MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension; Sildenafil Citrate

Study Results

No Results Posted as of Feb 1, 2021