NCT00432978

Brief Summary

This study is to determine whether bosentan will alter exercise capacity after rapid ascent to high altitude. We hypothesize that bosentan administration will improve arterial oxygenation and exercise capacity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2007

Completed
Last Updated

April 18, 2007

Status Verified

April 1, 2007

First QC Date

February 6, 2007

Last Update Submit

April 17, 2007

Conditions

AltitudePulmonary Hypertension

Keywords

hypoxiaendothelinexercise

Outcome Measures

Primary Outcomes (2)

  • Exercise Capacity

  • Pulmonary artery systolic pressure

Secondary Outcomes (1)

  • Hemoglobin oxygen saturation

Interventions

Bosentan administrationDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal healthy subjects aged 18 - 55 years

You may not qualify if:

  • Pregnancy
  • Heart, lung or liver disease
  • Use of glyburide, cyclosporin A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Loma Linda Healthcare System

Loma Linda, California, 92357, United States

Location

Related Publications (1)

  • Seheult RD, Ruh K, Foster GP, Anholm JD. Prophylactic bosentan does not improve exercise capacity or lower pulmonary artery systolic pressure at high altitude. Respir Physiol Neurobiol. 2009 Feb 28;165(2-3):123-30. doi: 10.1016/j.resp.2008.10.005. Epub 2008 Oct 11.

    PMID: 18977464DERIVED

MeSH Terms

Conditions

Hypertension, PulmonaryHypoxiaMotor Activity

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • James D Anholm, MD

    VA Loma Linda Healthcare System

    PRINCIPAL INVESTIGATOR

  • Katja Ruh, MD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED

Study Record Dates

First Submitted

February 6, 2007

First Posted

February 8, 2007

Study Start

July 1, 2006

Study Completion

February 1, 2007

Last Updated

April 18, 2007

Record last verified: 2007-04

Locations

US(1)