A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH. (CHEST-1)

Bayer

Status and phase: Completed; Phase 3

Conditions: Pulmonary Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00855465

2007-000072-16 (EudraCT Number)

11348

Details and patient eligibility

About

The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

Full description

Adverse event data will be covered in Adverse events section.

Enrollment: 262 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery.

Exclusion criteria

• All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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262 participants in 2 patient groups, including a placebo group

Riociguat (Adempas, BAY63-2521)_individual dose titration

Experimental group

Description:

Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks

Treatment:

Drug: Riociguat (Adempas, BAY63-2521)

Placebo

Placebo Comparator group

Description:

Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks

Treatment:

Drug: Placebo