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

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.
ClinicalTrials.gov Identifier: NCT00878943
Recruitment Status : No longer available
First Posted : April 9, 2009
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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
Pulmonary Arterial Hypertension Drug: Sildenafil citrate

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.



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

Information from the National Library of Medicine

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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

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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00878943     History of Changes
Other Study ID Numbers: A1481269
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017

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