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An Open Label Access Study For Subjects Who Completed A1481156

Expanded access is no longer available for this treatment.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: April 19, 2012
Last updated: March 7, 2017
Last verified: March 2017
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.

Condition Intervention
Pulmonary Arterial Hypertension
Drug: Access program - sildenafil citrate, Viagra, Revatio

Study Type: Expanded Access     What is Expanded Access?
Official Title: A Local, Multicentre, Open Label Access Study, To Provide Sildenafil Therapy For Subjects Who Completed A1481156 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil For Subjects In India

Resource links provided by NLM:

Further study details as provided by Pfizer:

Study Start Date: November 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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:

  • 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.
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Please refer to this study by its identifier: NCT01582438

CARE Hospital
Hyderabad, Andhra Pradesh, India, 500 001
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01582438     History of Changes
Other Study ID Numbers: A1481304
Study First Received: April 19, 2012
Last Updated: March 7, 2017

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Citric Acid
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Calcium Chelating Agents
Chelating Agents
Sequestering Agents processed this record on May 25, 2017