Effects of Oral Sildenafil on Mortality in Adults With PAH

Phase 4TerminatedNCT02060487

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.385 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

385

Conditions

Pulmonary Arterial Hypertension

Interventions

sildenafil citrateDRUG

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

sildenafil citrateDRUG

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

sildenafil citrateDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (82)

Outcomes

Primary Outcomes

Overall Survival

In this outcome measure number of deaths during the study were reported.

Time frame: Day 1 of study treatment up to date of death (within a maximum duration of 2102 days)

Secondary Outcomes

Number of Participants With Clinical Worsening Events

Clinical worsening was defined as all-cause mortality, non-elective hospital stay for worsening pulmonary arterial hypertension (PAH) (including but not limited to right heart failure \[RHF\], initiation of intravenous (IV) prostanoids, lung transplantation, or septostomy) or disease progression. Disease progression was defined as a reduction from baseline in the 6-Minute Walk Distance (6MWD) test by 15% and worsening functional class from baseline, both confirmed by second test within 2 weeks of study treatment.

Time frame: Day 1 of study treatment up to date of clinical worsening event (within a maximum duration of 2080 days)

Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 6

6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Analysis was performed using mixed model for repeated measures (MMRM), adjusted for baseline 6MWD and for randomization stratification factors: PAH treatment at study entry and etiology of PAH.

Time frame: Baseline, Month 6

Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 12

Time frame: Baseline, Month 12

Data from ClinicalTrials.gov

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Emory University Investigational Drug Services

Atlanta, Georgia, United States

The Emory Clinic

Atlanta, Georgia, United States

Frederik Meijer Heart & Vascular Institute Cardiovascular Research