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

Last updated on October 13, 2019

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

NCT00878943
Pfizer
No longer available
Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study

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[email protected]

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Descriptive Information
Brief TitleOpen Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study
Brief SummaryIn 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 DescriptionNot Provided
Study TypeExpanded Access
InterventionDrug: 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 StatusNo longer available
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesIndia
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00878943
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now