Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In an earlier study, sildenafil citrate administered to patients of PAH led to improvement in pulmonary arterial pressure, cardiac output, quality of life, and other parameters as compared to placebo. This protocol provides mechanism for patients who have clinical deterioration on other PAH approved therapies to have access to sildenafil prior to marketing authorization in India.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Open Label Access Study For Subjects Who Completed A1481156

NCT01582438

Pulmonary Arterial Hypertension

NO_LONGER_AVAILABLE

To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks

NCT00946114

Pulmonary Hypertension

COMPLETED

To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.

NCT00430716

Pulmonary Arterial Hypertension

TERMINATED PHASE4

Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil

NCT00866983

Pulmonary Arterial Hypertension

NO_LONGER_AVAILABLE

Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

NCT00454207

Pulmonary Hypertension

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Arterial Hypertension

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sildenafil citrate

20 mg tablet to be taken thrice daily for 1 year

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject who complete the A1481244 study and require Sildenafil (Revatio TM) 20 mg TID therapy.
* All women of childbearing potential must use adequate contraception throughout the study and four weeks after completion of the study

Exclusion Criteria

* Pregnant or lactating women
* Participation in other studies during study participation
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No