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

Primary Purpose

Hypoxia-Induced Pulmonary Artery Hypertension

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Bosentan
Bosentam TRACLEER
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxia-Induced Pulmonary Artery Hypertension focused on measuring Hypoxia-induced pulmonary artery hypertension, High-altitude pulmonary oedema, ETA receptor antagonist

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: 20 non smoker healthy volunteers : 10 resistant to high-altitude pulmonary oedema and 10 susceptible subjects, without history of cardiac or pulmonary disease or asthma, after a complete clinical examination and safety laboratory measurements prior to randomization, and after giving informed written consent. Exclusion Criteria: antecedent of lung disease notably with asthmatic antecedent or HTAP antecedent of heart disease female genital organ systolic blood pressure < 85 mmHg or > 160 mmHg after 5 minutes of lengthened rest. sentimentality in a medicine, in particular in a bosentan or in one of the excipients of the tablet. hepatic incapacity moderated to severe correspondent in the class B or C of the classification of Child-Pugh (cf Pharmacokinetics) Rate serous hepatic aminotransferases, aspartate aminotransferases( ASAT) and\or alanine aminotransférases ( ALAT), superior to 3 times the superior limit of the normal before the started of the treatment. pointed or chronic systematic diseases. presence of antibody anti-HIV, of anti-HVC antibody, antigens Hbs and\or antibody anti-Hbc. - active addiction to smoking. alcohol abuse and of toxins. Taking of concomitant medicines except those allowed the chapter concomitant treatments. signs, symptoms or values of the biological examinations situated except the clinically acceptable values for healthy subjects with or without antecedent of OPHA. common(current) ingestion of excessive quantities of tea, coffee(cafe), chocolate and\or drinks containing some caffeine (> 5 cups / day, is approximately 500 mg of caffeine a day). consumption of juice of grapefruit and\or herb tea on base of St. John's wort Don of blood in 3 months preceding the study. Persons in period of exclusion on the national file of the persons lending itself to the biomedical search(research) without direct individual profit. refusal or linguistic or psychic incapacity to sign the lit(enlightened) assent. subject which can not submit itself to the constraints of the protocol (for example, not cooperative, incapable to go(surrender) to the visits of follow-up and probably incapable to finish the study

Sites / Locations

  • Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Experimental and Placebo Comparator administered in random order during to successive experimental phase

Experimental and Placebo Comparator administered in random order during to successive experimental phase

Outcomes

Primary Outcome Measures

To investigate whether bosentan compared to placebo reduces hypoxia-induced increase in pulmonary artery pressure in healthy subjects and in subjects with past history of high-altitude pulmonary oedema

Secondary Outcome Measures

To compare
pulmonary artery pressure response to exercise,
exercise capacity,
oxygen desaturation,
and to assess the global safety

Full Information

First Posted
December 1, 2005
Last Updated
October 16, 2008
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00260819
Brief Title
Effects of Bosentan (Tracleer) in the Course of Pulmonary Artery Hypertension Induced by Hypoxia
Official Title
Effects of Bosentan (Tracleer) in the Course of Pulmonary Artery Hypertension Induced by Hypoxia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Patients will be examined on a variable load supine bicycle ergometer. The exercise table will be tilted laterally by 20 to 30 degrees to the left. PASP will be assessed using Doppler echocardiography at rest and during during supine bicycle exercise in NORMOXIA and hypoxia. Exposure to normobaric hypoxia will be performed by breathing a hypoxic gas mixture at sea level during 90 minutes (12,3 % O2 + 87.7 % N2) reproducing conditions at 4300 m altitude. Exercise will be started at an initial workload of 40 watts and increased by 10 watts every minute to reach a workload level defined by a heart rate (HR) corresponding to 50% of the estimated maximal aerobic power

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia-Induced Pulmonary Artery Hypertension
Keywords
Hypoxia-induced pulmonary artery hypertension, High-altitude pulmonary oedema, ETA receptor antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Experimental and Placebo Comparator administered in random order during to successive experimental phase
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Experimental and Placebo Comparator administered in random order during to successive experimental phase
Intervention Type
Drug
Intervention Name(s)
Bosentan
Other Intervention Name(s)
TRACLEER
Intervention Description
Single dose administration of 250 mg bosentan (2 pills Tracleer 125 mg) or placebo
Intervention Type
Drug
Intervention Name(s)
Bosentam TRACLEER
Intervention Description
Single dose administration of 250 mg bosentan (2 pills Tracleer 125 mg) or placebo
Primary Outcome Measure Information:
Title
To investigate whether bosentan compared to placebo reduces hypoxia-induced increase in pulmonary artery pressure in healthy subjects and in subjects with past history of high-altitude pulmonary oedema
Time Frame
during the study
Secondary Outcome Measure Information:
Title
To compare
Time Frame
during the study
Title
pulmonary artery pressure response to exercise,
Time Frame
during the study
Title
exercise capacity,
Time Frame
during the study
Title
oxygen desaturation,
Time Frame
during the study
Title
and to assess the global safety
Time Frame
during the study

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 20 non smoker healthy volunteers : 10 resistant to high-altitude pulmonary oedema and 10 susceptible subjects, without history of cardiac or pulmonary disease or asthma, after a complete clinical examination and safety laboratory measurements prior to randomization, and after giving informed written consent. Exclusion Criteria: antecedent of lung disease notably with asthmatic antecedent or HTAP antecedent of heart disease female genital organ systolic blood pressure < 85 mmHg or > 160 mmHg after 5 minutes of lengthened rest. sentimentality in a medicine, in particular in a bosentan or in one of the excipients of the tablet. hepatic incapacity moderated to severe correspondent in the class B or C of the classification of Child-Pugh (cf Pharmacokinetics) Rate serous hepatic aminotransferases, aspartate aminotransferases( ASAT) and\or alanine aminotransférases ( ALAT), superior to 3 times the superior limit of the normal before the started of the treatment. pointed or chronic systematic diseases. presence of antibody anti-HIV, of anti-HVC antibody, antigens Hbs and\or antibody anti-Hbc. - active addiction to smoking. alcohol abuse and of toxins. Taking of concomitant medicines except those allowed the chapter concomitant treatments. signs, symptoms or values of the biological examinations situated except the clinically acceptable values for healthy subjects with or without antecedent of OPHA. common(current) ingestion of excessive quantities of tea, coffee(cafe), chocolate and\or drinks containing some caffeine (> 5 cups / day, is approximately 500 mg of caffeine a day). consumption of juice of grapefruit and\or herb tea on base of St. John's wort Don of blood in 3 months preceding the study. Persons in period of exclusion on the national file of the persons lending itself to the biomedical search(research) without direct individual profit. refusal or linguistic or psychic incapacity to sign the lit(enlightened) assent. subject which can not submit itself to the constraints of the protocol (for example, not cooperative, incapable to go(surrender) to the visits of follow-up and probably incapable to finish the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel AZIZI, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75908 cedex 15
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
10732898
Citation
Grunig E, Mereles D, Hildebrandt W, Swenson ER, Kubler W, Kuecherer H, Bartsch P. Stress Doppler echocardiography for identification of susceptibility to high altitude pulmonary edema. J Am Coll Cardiol. 2000 Mar 15;35(4):980-7. doi: 10.1016/s0735-1097(99)00633-6.
Results Reference
result

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

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