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The Efficacy and Safety of Vardenafil in the Treatment of Pulmonary Arterial Hypertension

NCT00718952 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-02-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of vardenafil in the treatment of pulmonary arterial hypertension.

Conditions

  • Pulmonary Hypertension

Interventions

DRUG

Vardenafil

vardenafil tablet 5mg once-daily orally in the first 4 weeks while 5mg twice-daily orally in the following 8 weeks.

DRUG

Placebo

Placebo tablet 5mg once-daily orally in the first 4 weeks while 5mg twice-daily orally in the following 8 weeks.

DRUG

Vardenafil

Patients in all the 2 arms will take vardenafil tablet 5mg twice-daily orally from week 13 to week 24(open-label).

Sponsors & Collaborators

  • Tongji University

    lead OTHER

Principal Investigators

  • Zhi-Cheng Jing, MD · Shanghai Pulmonary Hospital Affiliated to Tongji University, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-12-31
Completion
2010-02-28

Countries

  • China

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 NCT00718952 on ClinicalTrials.gov