- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00260819
Effects of Bosentan (Tracleer) in the Course of Pulmonary Artery Hypertension Induced by Hypoxia
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Paris, France, 75908 Cedex 15
- Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Experimental and Placebo Comparator administered in random order during to successive experimental phase
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Single dose administration of 250 mg bosentan (2 pills Tracleer 125 mg) or placebo
Other Names:
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Placebo Comparator: 2
Experimental and Placebo Comparator administered in random order during to successive experimental phase
|
Single dose administration of 250 mg bosentan (2 pills Tracleer 125 mg) or placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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during the study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare
Time Frame: during the study
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during the study
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pulmonary artery pressure response to exercise,
Time Frame: during the study
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during the study
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exercise capacity,
Time Frame: during the study
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during the study
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oxygen desaturation,
Time Frame: during the study
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during the study
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and to assess the global safety
Time Frame: during the study
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during the study
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Collaborators and Investigators
Investigators
- Principal Investigator: Michel AZIZI, MD,PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Signs and Symptoms, Respiratory
- Hypertension, Pulmonary
- Hypertension
- Pulmonary Arterial Hypertension
- Hypoxia
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Endothelin Receptor Antagonists
- Bosentan
Other Study ID Numbers
- P050502
- AOR05038
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of ZurichActive, not recruitingPulmonary Artery Hypertension | Chronic Thromboembolic Pulmonary Hypertension | Pulmonary Vascular DiseaseSwitzerland
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