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

Expanded access is currently available for this treatment.
Verified November 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT01897740
First Posted: July 12, 2013
Last Update Posted: November 9, 2017
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.
Information provided by (Responsible Party):
Pfizer
  Purpose
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 Intervention
Pulmonary Arterial Hypertension Drug: sildenafil

Study Type: Expanded Access     What is Expanded Access?
Available for Individual Patients
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01897740


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Russian Federation
Moscow Research Institute of Pediatrics and Pediatric Surgery
Moscow, Russian Federation, 125412
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01897740     History of Changes
Other Study ID Numbers: A1481307
First Submitted: July 8, 2013
First Posted: July 12, 2013
Last Update Posted: November 9, 2017
Last Verified: November 2017

Keywords provided by Pfizer:
sildenafil
pulmonary arterial hypertension
PAH

Additional relevant MeSH terms:
Hypertension
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