Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

Expanded access is currently available for this treatment.
Verified October 2014 by Pfizer
Information provided by (Responsible Party):
Pfizer Identifier:
First received: April 8, 2009
Last updated: October 30, 2014
Last verified: October 2014

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 Intervention Phase
Pulmonary Arterial Hypertension
Drug: Sildenafil citrate
Phase 4

Study Type: Expanded Access     What is 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.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Study Start Date: April 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sildenafil citrate
    20 mg tablet to be taken thrice daily for 1 year

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00878943

Contact: Pfizer Call Center 1-800-718-1021

The Institute of Medical Sciences, CARE Hospital
Hyderabad, Andra Pradesh, India, 500 001
Mehta Hospital & Cardiopulmonary Care Center
Ahmedabad, Gujarat, India, 380 054
Bankers Heart Institute
Vadodara, Gujarat, India, 390 015
St Johns Medical College Hospital
Bangalore, Karnataka, India, 560 034
Metro Multispeciality Hospital
Noida, Uttar Pradesh, India, 201301
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT00878943     History of Changes
Other Study ID Numbers: A1481269
Study First Received: April 8, 2009
Last Updated: October 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Open label access
pulmonary arterial hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents processed this record on November 24, 2014