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An Open Label Access Study For Subjects Who Completed A1481156 | Clinical Trials | Clareo Health

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An Open Label Access Study For Subjects Who Completed A1481156

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

NCT01582438•Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

12 - 30 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

CARE Hospital

Hyderabad, Andhra Pradesh, India

Key Dates

Last Updated

January 29, 2021

Conditions

Pulmonary Arterial Hypertension

Interventions

Access program - sildenafil citrate, Viagra, Revatio

DRUG

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

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Healthy Volunteers, Pulmonary Arterial Hypertension

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RECRUITINGPHASE3

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

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Pulmonary Arterial Hypertension

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RECRUITINGPHASE1

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Open Label Access Study For Subjects Who Completed A1481156

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

COMPERA / COMPERA-KIDS

The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization