Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) - Full Text View

Purpose

The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: bosentan	Phase III

Genetics Home Reference related topics:

pulmonary arterial hypertension

MedlinePlus related topics:

High Blood Pressure Pulmonary Hypertension

ChemIDplus related topics:

Bosentan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Long-Term Open-Label Extension Study in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Who Completed Protocol AC-052-366 (BENEFIT)

Further study details as provided by Actelion:

Primary Outcome Measures:

Change from baseline to all assessed time points in 6-minute walk test distance
Change from baseline to all assessed time points in Borg dyspnea index
Change from baseline to all assessed time points in New York Heart Association (NYHA) class
Time to clinical worsening up to end-of-study

Secondary Outcome Measures:

Adverse event(s) leading to premature discontinuation of study medication
Serious adverse events up to 28 days after study medication discontinuation
Occurrence of liver function test (ALT and/or AST) abnormality and hemoglobin abnormality

Enrollment:	148
Study Start Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients having completed the 16-week treatment period of protocol AC-052-366
Signed informed consent

Exclusion Criteria:

Any major violation of protocol AC-052-366
Pregnancy or breast-feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319111

Show 30 Study Locations

Sponsors and Collaborators

Actelion

More Information

Responsible Party:	Actelion ( Sebastien Roux, MD )
Study ID Numbers:	AC-052-370, BENEFIT OL
First Received:	April 26, 2006
Last Updated:	December 10, 2007
ClinicalTrials.gov Identifier:	NCT00319111
Health Authority:	United States: Food and Drug Administration

Keywords provided by Actelion:

pulmonary hypertension

bosentan

BENEFIT

CTEPH

inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Study placed in the following topic categories:

Respiratory Tract Diseases

Hypertension, Pulmonary

Lung Diseases

Vascular Diseases

Bosentan

Hypertension

Additional relevant MeSH terms:

Therapeutic Uses

Cardiovascular Diseases

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00319111