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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 February 2013 |
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Main ID: |
NCT00777985 |
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Date of registration:
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22/10/2008 |
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Primary sponsor: |
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Public title:
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Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea
BOSAS |
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Scientific title:
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Cardiovascular Consequences of Obstructive Sleep Apnea (OSA): Role of Endothelin and Preventive Effects of Bosentan |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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28 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00777985 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Marie FAURE, PharmD, PhD |
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Address:
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Telephone:
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33 4 76 63 74 75 |
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Email:
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marie.faure@ujf-grenoble.fr |
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Affiliation:
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Name:
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Marie FAURE, PharmD, PhD |
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Address:
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Telephone:
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33 476 63 74 75 |
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Email:
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marie.faure@ujf-grenoble.fr |
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Affiliation:
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Name:
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Sandrine H Launois, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Grenoble |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Documented obstructive sleep apnea
- with untreated mild systemic hypertension
Exclusion Criteria:
- pregnancy or lactation
- daytime alveolar hypoventilation
- severe arterial hypertension (systolic pressure > 180 mmHg; diastolic pressure > 110
mmHg)
- treatment with anti-hypertensive drugs
- cardiovascular disorder other than mild hypertension
- severe daytime sleepiness (score on the EPWORTH sleepiness scale =15) or at-risk
occupation
- contra-indication to nCPAP treatment
- known allergy to bosentan
- active treatment with a drug whose efficacy is reduced by cytochromes P450, 2C9, 3A4
and2C19 isoenzyme activation
- active treatment with a drug acting on systemic arterial blood pressure or
endothelial function
- liver or kidney dysfunction
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Obstructive Sleep Apnea
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Intervention(s)
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Device: nasal continuous positive airway pressure (CPAP)
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Drug: bosentan
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Primary Outcome(s)
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24 hour mean diastolic blood pressure
[Time Frame: before and after each treatment completion (4 weeks)]
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Secondary Outcome(s)
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carotid Intima Media Thickness
[Time Frame: before and after each treatment completion (4 weeks)]
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Circulating Big ET1 and ET1 levels
[Time Frame: before and after each treatment completion (4 weeks)]
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Circulating inflammation markers (RANTES, MCP-1, TNF-alpha, INF-gamma, IL-6, IL-10 and TGF-gamma
[Time Frame: before and after each treatment completion (4 weeks)]
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mean 24 hour nocturnal blood pressure
[Time Frame: before and after each treatment completion (4 weeks)]
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mean 24 hour systemic systolic blood pressure
[Time Frame: before and after each treatment completion (4 weeks)]
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Peripheral Arterial Tonometry measure
[Time Frame: before and after each treatment completion (4 weeks)]
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Secondary ID(s)
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0722
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2007-005333-11
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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