Pulmonary Artery Remodelling With Bosentan | NCT00595049

Studies
Pulmonary Artery Remodelling With Bosentan

NCT00595049

Sponsor

Actelion

Status

Completed

Last Update Posted

Jun 3, 2026Actual

Enrollment

11Actual

Phase

Phase 4

Conditions

Hypertension, Pulmonary

Interventions

bosentan

Countries

Australia

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

Status Module

Record Verification Date

Jun 2026

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

May 31, 2006Actual

Primary Completion Date

Dec 31, 2008Actual

Completion Date

Jun 30, 2010Actual

First Submitted Date

Jan 7, 2008

First Submission Date that Met QC Criteria

Jan 7, 2008

First Posted Date

Jan 16, 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

Jun 1, 2026

Last Update Posted Date

Jun 3, 2026Actual

Description Module

Brief Summary

The main purpose of this study is to investigate whether bosentan (Tracleer®) affects the wall thickness of the pulmonary arteries in patients with idiopathic pulmonary arterial hypertension (iPAH) and PAH related to systemic sclerosis (PAH-SSc).

The second purpose is to investigate if bosentan affects the enlargement of small vessels in the lungs in response to natural chemicals in patients with iPAH and PAH-SSc.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Label	Type	Description	Intervention Names
bosentan	Experimental		Drug: bosentan

Name	Type	Description	Arm Group Labels	Other Names
bosentan	Drug	Bosentan 62.5 mg bid for 4 weeks, then 125 mg bid	bosentan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline (BL) to 6 mths in the IVUS-derived measurement of pulmonary artery wall thickness.		Baseline to 6 months
Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to actylcholine (Ach).		Baseline to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Change from BL to 6 mths in each of the IVUS derived pulmonary artery parameters.		Baseline to 6 months
Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to sodium nitroprusside.		Baseline to 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria : · Men or women >18 years of age.·

Symptomatic (modified NYHA class III) iPAH or PAH-SSc·
PAH confirmed by right heart catheterization performed within 3 months before enrolment mPAP > 25 mmHg, PCWP < 15 mmHg and PVR > 3 mmHg/l/min.
Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception during study treatment and for 3 months after study treatment termination.
Bosentan naïve patients

Exclusion Criteria : · PAH other than iPAH or PAH-SSc

Significant vasoreactivity during right heart catheterization defined as a fall in mPAP to < 40 mmHg with a decrease >= 10 mmHg and with a normal cardiac index (>= 2.5 l/min.m2)· Severe obstructive lung disease: FEV1/FVC < 0.5
Severe restrictive lung disease: TLC < 0.7 of normal predicted value
Hemoglobin <75% of the lower limit of the normal range· Systolic blood pressure < 85 mmHg
Body weight < 40 kg
Pregnancy or breast-feeding
Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
Baseline aminotransferases, i.e., aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT) > 3 times the upper limit of the normal (ULN) range.
Treatment for iPAH or PAH-SSc within 1 month before start of study treatment, excluding warfarin and acute administration of vasodilators for vascular reactivity testing during heart catheterization.
Treatment with epoprostenol or other prostacyclin analogs for iPAH or PAH-SSc within 1 month before start of study treatment
Treatment with glibenclamide (glyburide), fluconazole ketoconazole or ritonavir within 1 week before start of study treatment.
Current treatment with cyclosporine A or tacrolimus
Hypersensitivity to bosentan or any of the excipients of its formulation.
Patient who received an investigational drug (such as sildenafil) within 3 months before start of study treatment
Conditions that prevent compliance with the protocol or adherence to therapy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006976	Hypertension, Pulmonary
D006973	Hypertension
D012598	Sclerosis
D045743	Scleroderma, Diffuse

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals