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A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.

NCT00159913 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2021-02-18

Study results available
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Summary

This is a clinical research study designed to evaluate sildenafil for the treatment of Pulmonary Arterial Hypertension in children, aged 1 to 17 years. The purpose of the study is to assess the efficacy, safety, and pharmacokinetics of 16 weeks of chronic treatment with oral sildenafil given in three different doses, compared to placebo (inactive treatment). Efficacy will be measured by exercise and hemodynamics. Patients who complete this trial may be eligible to take part in an extension study, in which all patients will receive active treatment of sildenafil.

Conditions

  • Pulmonary Arterial Hypertension, Children

Interventions

DRUG

Sildenafil citrate

oral; 20mg, 40mg and 80 mg; 3 times a day(TID)

DRUG

Sildenafil citrate

oral; 10mg, 20mg and 40mg; 3 times a day(TID)

DRUG

Placebo

oral; 3 times a day(TID)

DRUG

Sildenafil citrate

oral; 10 mg; 3 times a day(TID)

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
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Guatemala
  • Hungary
  • India
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Peru
  • Poland
  • Russia
  • Sweden
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

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 NCT00159913 on ClinicalTrials.gov