BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension (CHEST-2)

Bayer

Status and phase: Completed; Phase 3

Conditions: Pulmonary Hypertension

Treatments: Drug: Riociguat (Adempas, BAY63-2521)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00910429

11349 (Registry Identifier)

2008-003539-19 (EudraCT Number)

Details and patient eligibility

About

Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.

Enrollment: 237 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1

Exclusion criteria

• Patients who have an ongoing serious adverse event from CHEST 1 that is assessed as related to BAY63-2521 are not allowed to participate in the extension trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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237 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Riociguat (Adempas, BAY63-2521)