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An Open Label Access Study For Subjects Who Completed A1481156

Last updated on November 15, 2019

FOR MORE INFORMATION
Study Location
CARE Hospital
Hyderabad, Andhra 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
12-30 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects who have completed study A1481156 and are judged by the Investigator to
derive clinical benefit from continuous treatment with sildenafil citrate therapy.

- Subjects with pulmonary arterial hypertension (PAH ) being treated at a study site in
India

- Subjects who are willing and able to comply with scheduled visits, treatment plan, and
other study procedures

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Pregnant or lactating female subjects.

- Current participation in other studies and during study participation, except for the
A1481304 follow-up period.

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration and, in the judgment of the investigator, would
make the subject inappropriate for entry into this study.

NCT01582438
Pfizer
No longer available
An Open Label Access Study For Subjects Who Completed A1481156

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Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief TitleAn Open Label Access Study For Subjects Who Completed A1481156
Brief SummaryThe purpose of this study is to provide sildenafil therapy to subjects who have completed the A1481156 study for the treatment of Pulmonary Arterial Hypertension (PAH) in India and are judged by the Investigator to derive clinical benefit from continued treatment with sildenafil citrate. Sildenafil citrate will be supplied for the treatment of Pulmonary Arterial Hypertension (PAH) until the subject continues to derive benefits from the treatment. The treating physicians (and the sponsor) will be responsible for reporting serious adverse events.
Detailed DescriptionNot Provided
Study TypeExpanded Access
InterventionDrug: Access program - sildenafil citrate, Viagra, Revatio
The recommended dose is 20 mg TID for subjects with body weight > 20 kg and 10 mg TID for subjects with body weight ? 20 kg. If subject is 18 years of age or older, the recommended dose is 20 mg TID, regardless of body weight. If a subject was receiving a higher dose in study A1481156 and the investigator believes that the subject requires continued treatment on that dose, or if dose reduction is judged to be associated with pulmonary arterial hypertension (PAH) deterioration in a particular subject, the higher dose may be made available, as judged on an individual basis on discussion with the sponsor.
Other Name: sildenafil citrate, Viagra, Revatio
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 NumberNCT01582438
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 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