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NCT00260819
Effects of Bosentan (Tracleer) in the Course of Pulmonary Artery Hypertension Induced by Hypoxia
Phase 1 trial testing Bosentan in Hypoxia-Induced Pulmonary Artery Hypertension in 20 participants. Completed in 1 April 2008.
1 April 2008
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 January 2006 |
| Primary completion | 1 April 2008 |
| Estimated completion | 1 April 2008 |
| Sites | 1 location across France |
Drugs / interventions tested
- Bosentan (BOSENTAN) — full drug profile →
- Bosentam TRACLEER — full drug profile →
Conditions studied
- Hypoxia-Induced Pulmonary Artery Hypertension — all drugs for Hypoxia-Induced Pulmonary Artery Hypertension →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
Adults 18 to 50, male only, with Hypoxia-Induced Pulmonary Artery Hypertension. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00260819
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Bosentan
Trials testing the same drug.
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- NCT05723874 — A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood · Phase 1 · completed
- NCT04158635 — Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer · Phase 1 · recruiting
- NCT05072106 — Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors · Phase 1 · completed
- NCT04068272 — Safety of Bosentan in Type II Diabetic Patients · Phase 1 · completed
Other Assistance Publique - Hôpitaux de Paris trials
Trials by the same sponsor.
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- NCT07499492 — Red Blood Cell Transfusion to Optimize Extubation · NA · not yet recruiting
- NCT07379918 — Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer · recruiting
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- NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00260819 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 16 October 2008
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00260819.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing