Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

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

Official Title

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

Conditions

• Pulmonary Hypertension

Study Type

Interventional

Study Design

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Details

• Primary Outcomes: 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 Outcomes: 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

Study Start

February 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 80 Years
• Genders Eligible for Study: Both

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

Total Enrolment

128 (expected)

Contact Details

The Prince Charles Hospital , Brisbane, 4032, Australia; Not yet recruiting