Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study

NCT00878943

Last updated date
Study Location
The Institute of Medical Sciences, CARE Hospital
Hyderabad, Andra Pradesh, 500 001, India
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Arterial Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study
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.
Detailed Description Not Provided
Study Type Expanded Access
Intervention Drug: Sildenafil citrate
20 mg tablet to be taken thrice daily for 1 year
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT00878943
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2017