You are here

An Open Label Access Study For Subjects Who Completed A1481156

Last updated on May 9, 2018

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.
Show details

- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Familial Persistent Pulmonary Hypertension
NCT01720524
All Genders
0+
Years
Multiple Sites
Pulmonary Arterial Hypertension
NCT02060487
All Genders
18+
Years
Multiple Sites
Pulmonary Arterial Hypertension
NCT01897740
All Genders
10+
Years
Moscow,
An Open Label Access Study For Subjects Who Completed A1481156
The 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.
Not Provided
Expanded Access
Drug: 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
Not Provided
 
No longer available
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01582438
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now