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

NCT01897740 | Unknown

• 1 other identifier: A1481307
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

sildenafil; pulmonary arterial hypertension; PAH

Interventions

sildenafil DRUG

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 Criteria

• Age: 10 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (1)

Moscow Research Institute of Pediatrics and Pediatric Surgery

Moscow, 125412, Russia

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 12, 2013
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

RU (1)