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A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children

NCT00159874 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2021-02-01

Study results available
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Summary

Active treatment, dose-blinded extension study evaluating the safety and long term efficacy of sildenafil citrate in children with PAH.

Conditions

Interventions

DRUG

Sildenafil citrate

Oral, subjects with body weight ≥8 - 20 kg: 20 mg 3 times a day (tid) subjects with body weight \>20 - 45 kg: 40 mg 3 times a day (tid) subjects with body weight \>45 kg: 80 mg 3 times a day (tid)

DRUG

Sildenafil citrate

Oral,10 mg 3 times a day (tid), only subjects with body weight \>20 kg

DRUG

Sildenafil citrate

Oral, subjects with body weight ≥8 - 20 kg: 10 mg 3 times a day (tid); subjects with body weight \>20 - 45 kg: 20 mg 3 times a day (tid); subjects with body weight \>45 kg: 40 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
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

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

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 NCT00159874 on ClinicalTrials.gov