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

Actelion Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Pulmonary Hypertension

Treatments: Drug: bosentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00319111

BENEFIT OL

AC-052-370

Details and patient eligibility

About

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

Enrollment: 151 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients having completed the 16-week treatment period of protocol AC-052-366 (NCT00313222)
• Signed informed consent

Exclusion criteria

• Any major violation of protocol AC-052-366 (NCT00313222)
• Pregnancy or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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151 participants in 1 patient group

Bosentan

Experimental group

Description:

Open label bosentan treatment

Treatment:

Drug: bosentan