Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01897740
Recruitment Status : Available
First Posted : July 12, 2013
Last Update Posted : January 31, 2018
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is 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, prior to reimbursement and availability for subjects in the Russian Federation.

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Drug: sildenafil

Study Type : Expanded Access
  Individual Patient
Official Title: A Local, Single-centre, Extension, 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, Prior To Reimbursement And Availability For Subjects In Russian Federation

Intervention Details:
    Drug: sildenafil
    tablets of sildenafil 20 mg 3 times a day 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients Who Completed study A1481156 and Are Judged by the Investigator to Derive Clinical Benefit from Continued Treatment with Sildenafil, Prior to Reimbursement and Availability for Subjects in Russian Federation.
  • Child bearing age women should have appropriate contraception.
  • Signed informed consent. Patients who have a wish and possibility to follow treatment regimens in terms of the study.

Exclusion Criteria:

  • Pregnant and lactating women.
  • Participation in other studies in the current moment or during study period except of A1481156.
  • Patients with severe acute or chronic diseases psychiatric disorders or laboratory abnormalities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01897740

Contact: Pfizer Call Center 1-800-718-1021

Russian Federation
Moscow Research Institute of Pediatrics and Pediatric Surgery
Moscow, Russian Federation, 125412
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01897740     History of Changes
Other Study ID Numbers: A1481307
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Keywords provided by Pfizer:
pulmonary arterial hypertension

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents