Status:
COMPLETED
Effects of Bosentan (Tracleer) in the Course of Pulmonary Artery Hypertension Induced by Hypoxia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hypoxia-Induced Pulmonary Artery Hypertension
Eligibility:
MALE
18-50 years
Phase:
PHASE1
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00260819
Start Date
January 1 2006
End Date
April 1 2008
Last Update
October 17 2008
Active Locations (1)
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1
Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou
Paris, France, 75908 cedex 15