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Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea

NCT ID: NCT00777985

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2012-01-31

Brief Summary

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The study will compared the effects of bosentan, an endothelin receptor antagonist, and nasal continuous positive airway pressure (nCPAP), obstructive sleep apnea current reference treatment, on diastolic blood pressure in untreated mildly hypertensive sleep apnea patients.

The hypothesis is that blocking endothelin receptors with a drug will have the same systemic blood pressure lowering effect than nCPAP in sleep apnea patients.

Detailed Description

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Conditions

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Obstructive Sleep Apnea Hypertension

Keywords

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Cardiovascular system Sleep Endothelial function Endothelin system

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

bosentan

Intervention Type DRUG

62.5 mg b.i.d for 4 weeks

2

Group Type ACTIVE_COMPARATOR

nasal continuous positive airway pressure (CPAP)

Intervention Type DEVICE

Daily application throughout sleep for 4 weeks

Interventions

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bosentan

62.5 mg b.i.d for 4 weeks

Intervention Type DRUG

nasal continuous positive airway pressure (CPAP)

Daily application throughout sleep for 4 weeks

Intervention Type DEVICE

Other Intervention Names

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TRACLEER

Eligibility 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Actelion

INDUSTRY

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandrine H Launois, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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CHU de Grenoble

Grenoble, , France

Site Status

Countries

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France

References

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Joyeux-Faure M, Jullian-Desayes I, Pepin JL, Cracowski JL, Baguet JP, Tamisier R, Levy P, Godin-Ribuot D, Launois SH. Comparison of continuous positive airway pressure and bosentan effect in mildly hypertensive patients with obstructive sleep apnoea: A randomized controlled pilot study. Respirology. 2016 Apr;21(3):546-52. doi: 10.1111/resp.12713. Epub 2015 Dec 8.

Reference Type RESULT
PMID: 26643404 (View on PubMed)

Other Identifiers

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2007-005333-11

Identifier Type: REGISTRY

Identifier Source: secondary_id

0722

Identifier Type: -

Identifier Source: org_study_id