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Effects of Bosentan (Tracleer) in the Course of Pulmonary Artery Hypertension Induced by Hypoxia

NCT00260819 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2008-10-17

No results posted yet for this study

Summary

Excessive rise in pulmonary artery pressure induced by low oxygen tension (hypoxia) is one of the factors implicated in high-altitude pulmonary oedema. Plasma ET1 increases in subjects exposed to high altitude and is correlated to pulmonary artery pressure.

The aim of the study is to investigate whether blockade of ET1 receptors would reduce the acute rise in systolic pulmonary artery pressure induced by hypoxia.

Conditions

  • Hypoxia-Induced Pulmonary Artery Hypertension

Interventions

DRUG

Bosentan

Single dose administration of 250 mg bosentan (2 pills Tracleer 125 mg) or placebo

DRUG

Bosentam TRACLEER

Single dose administration of 250 mg bosentan (2 pills Tracleer 125 mg) or placebo

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Michel AZIZI, MD,PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • France

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 NCT00260819 on ClinicalTrials.gov