Preventive Effects of Bosentan on the Systemic Cardiovasc... | NCT00777985

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

NCT00777985

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Dec 22, 2025Actual

Enrollment

19Actual

Phase

Phase 2

Conditions

Obstructive Sleep Apnea
Hypertension

Interventions

bosentan
nasal continuous positive airway pressure (CPAP)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-005333-11	Registry Identifier	EudraCT number

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Oct 22, 2008

First Submission Date that Met QC Criteria

Oct 22, 2008

First Posted Date

Oct 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2025

Last Update Posted Date

Dec 22, 2025Actual

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV
Actelion	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: bosentan
2	Active Comparator		Device: nasal continuous positive airway pressure (CPAP)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bosentan	Drug	62.5 mg b.i.d for 4 weeks	1	TRACLEER

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
24 hour mean diastolic blood pressure		before and after each treatment completion (4 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Peripheral Arterial Tonometry measure		before and after each treatment completion (4 weeks)
mean 24 hour systemic systolic blood pressure		before and after each treatment completion (4 weeks)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sandrine H Launois, MD PhD	University Hospital, Grenoble	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Grenoble		Grenoble		38043	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26643404	Result	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.

ID	Term
D020181	Sleep Apnea, Obstructive
D006973	Hypertension

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

ID	Term
D000077300	Bosentan
D045422	Continuous Positive Airway Pressure

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals