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

Expanded access is temporarily not available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00878943
First received: April 8, 2009
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

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 For A Year Prior To Availability Of Revatio For Patients In India.

Resource links provided by NLM:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878943

Locations
India
Pfizer Investigational Site
Hyderabad, Andra Pradesh, India, 500 001
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 054
Pfizer Investigational Site
Vadodara, Gujarat, India, 390 015
Pfizer Investigational Site
Bangalore, John Nagara, India, 560 034
Pfizer Investigational Site
Noida, Uttar Pradesh, India, 201301
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00878943     History of Changes
Other Study ID Numbers: A1481269
Study First Received: April 8, 2009
Last Updated: May 21, 2013
Health Authority: India: Ministry of Health

Keywords provided by Pfizer:
Open label access
sildenafil
pulmonary arterial hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Sildenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013