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

NCT ID: NCT00319111

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-04-30

Brief Summary

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

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bosentan

Open label bosentan treatment

Group Type: EXPERIMENTAL

bosentan

Intervention Type: DRUG

Oral bosentan

• Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
• Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)

Interventions

bosentan

Oral bosentan

• Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
• Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

BENEFIT OL

Identifier Type: -

Identifier Source: secondary_id

AC-052-370

Identifier Type: -

Identifier Source: org_study_id