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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:
ClinicalTrials.gov Identifier:
NCT00878943
First Posted: April 9, 2009
Last Update Posted: April 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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
Pulmonary Arterial Hypertension Drug: Sildenafil citrate

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
Study Completion Date: June 2015
Primary Completion Date: June 2015 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878943


Locations
India
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00878943     History of Changes
Other Study ID Numbers: A1481269
First Submitted: April 8, 2009
First Posted: April 9, 2009
Last Update Posted: April 18, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents