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Pulmonary Arterial Hypertension | Effects of Oral Sildenafil on Mortality in Adults With PAH

Pulmonary Arterial Hypertension research study

What is the primary objective of this study?

This is a blinded study in adult patients with PAH evaluating the relative effects of sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three times per day [TID]). In addition, the relative effects on clinical worsening and 6-minute walking distance (6MWD) will be assessed.

Who is eligible to participate?

Inclusion Criteria: Subjects ≥ 18 <75 years of age with any of the following conditions: - Idiopathic Primary Pulmonary Arterial Hypertension (IPAH) - PAH secondary to connective tissue disease - PAH with surgical repair (at least 5 years previously) of atrial septal defect (ASD),ventricular septal defect (VSD), patent ductus arteriosus (PDA) and aorto-pulmonary window - PAH diagnosis confirmed by right heart catheterization performed within 12 months prior to randomization - Functional Class II-IV; Baseline 6MWD ≥ 50 m. Exclusion Criteria: - Significant (ie, >2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation - History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation - History of pulmonary embolism; History of chronic lung disease / restrictive lung disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with impairment of lung function - No prior long term treatment with PDE-5 inhibitors - Treatment with bosentan OR riociguat within 3 months of randomization - Current treatment with nitrates or nitric oxide

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pulmonary Arterial Hypertension

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:sildenafil citratesildenafil citrate (PDE-5 inhibitor) 5 mg tablet TID until study treatment discontinued or end of study

Drug:sildenafil citratesildenafil citrate (PDE-5 inhibitor) 20 mg tablet TID until study treatment discontinued or end of study

Drug:sildenafil citratesildenafil citrate (PDE-5 inhibitor) 80 mg tablet TID until study treatment discontinued or end of study

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Low dose

Medium dose

High dose

Study Status

Recruiting

Start Date: September 22, 2014

Completed Date: December 31, 2023

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Overall Survival (OS)

Secondary Outcome: Time to first clinical worsening (TTCW) event

Study sponsors, principal investigator, and references

Principal Investigator: Pfizer CT.gov Call Center

Lead Sponsor: Pfizer

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02060487

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