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Effects of Oral Sildenafil on...

Effects of Oral Sildenafil on Mortality in Adults With PAH

NCT ID: NCT02060487

Last Updated: 2022-05-13

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-22

Study Completion Date

2021-02-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low dose

Group Type EXPERIMENTAL

sildenafil citrate

Intervention Type DRUG

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

Medium dose

Group Type EXPERIMENTAL

sildenafil citrate

Intervention Type DRUG

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

High dose

Group Type EXPERIMENTAL

sildenafil citrate

Intervention Type DRUG

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

Interventions

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sildenafil citrate

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

Intervention Type DRUG

sildenafil citrate

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

Intervention Type DRUG

sildenafil citrate

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

Intervention Type DRUG

Other Intervention Names

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Revatio Revatio Revatio

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Emory University Investigational Drug Services

Atlanta, Georgia, United States

Site Status