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Effects of Oral Sildenafil on Mortality in Adults With PAH

NCT02060487 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2022-05-13

Study results available
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Summary

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.

Conditions

Interventions

DRUG

sildenafil citrate

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

DRUG

sildenafil citrate

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

DRUG

sildenafil citrate

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

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-22
Primary Completion
2021-02-26
Completion
2021-02-26
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Bosnia and Herzegovina
  • Croatia
  • Czechia
  • Germany
  • Greece
  • Hong Kong
  • Israel
  • Latvia
  • Malaysia
  • Mexico
  • Poland
  • Romania
  • Russia
  • Serbia
  • Singapore
  • South Africa
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02060487 on ClinicalTrials.gov