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A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension

NCT00644605 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2021-02-01

No results posted yet for this study

Summary

To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day \[TID\]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.

Conditions

  • Hypertension, Pulmonary

Interventions

DRUG

sildenafil

sildenafil 40 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks

DRUG

sildenafil

sildenafil 80 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks; initially, patients received 40mg TID for one week and were then up-titrated to 80mg TID

DRUG

placebo

placebo by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks

DRUG

sildenafil

sildenafil 20 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks

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
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Completion
2003-11-30

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Czechia
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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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 NCT00644605 on ClinicalTrials.gov