Bosentan and Pulmonary Endothelial Function

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension

NCT00313222

Chronic Thromboembolic Pulmonary Hypertension

COMPLETED PHASE3

Pulmonary Artery Remodelling With Bosentan

NCT00595049

Hypertension, Pulmonary

COMPLETED PHASE4

Efficacy and Safety of Bosentan in Sickle Cell Disease (SCD) Patients Diagnosed With Pulmonary Hypertension (PH)

NCT00313196

Pulmonary Hypertension

TERMINATED PHASE3

Effects of Tracleer (Bosentan) on Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

NCT00317486

Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

COMPLETED PHASE4

Bosentan in Pulmonary Hypertension in Interstitial Lung Disease Treatment Study

NCT00637065

Pulmonary Hypertension Interstitial Lung Disease Idiopathic Pulmonary Fibrosis +1 more

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Arterial Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bosentan

62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months

Group Type EXPERIMENTAL

Bosentan

Intervention Type DRUG

62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bosentan

62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pulmonary arterial hypertension; idiopathic and connective tissue disease associated
* Confirmed or invasive haemodynamic:
* Mean pulmonary arterial pressure greater than or equal to 25 millimeters of mercury
* Pulmonary capillary wedge pressure less than 15 millimeters of mercury
* No prior pulmonary hypertension specific therapy
* Ability to provide informed consent

Exclusion Criteria

* Contra-indications to medications used to test endothelial function; acetylcholine, sodium nitroprusside, NG-Monomethyl-L-Arginine, L-arginine
* Advanced renal disease
* Previous allergic reaction to contrast agents

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No