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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 currently available for this treatment.
Verified October 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00878943
First received: April 8, 2009
Last updated: October 30, 2014
Last verified: October 2014

April 8, 2009
October 30, 2014
April 2009
December 2017   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00878943 on ClinicalTrials.gov Archive Site
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Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study
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.

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.

Not Provided
Expanded Access
Phase 4
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Pulmonary Arterial Hypertension
Drug: Sildenafil citrate
20 mg tablet to be taken thrice daily for 1 year
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Available
Not Provided
December 2017
December 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
India
 
NCT00878943
A1481269
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP