BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension (PATENT-2)

Bayer

Status and phase: Completed; Phase 3

Conditions: Hypertension, Pulmonary

Treatments: Drug: Riociguat (BAY63-2521)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00863681

12935

2008-003610-94 (EudraCT Number)

Details and patient eligibility

About

Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.

Enrollment: 396 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have completed 12 weeks of treatment in the double blind trial PATENT 1

Exclusion criteria

• Patients who have an ongoing serious adverse event from PATENT 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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396 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Riociguat (BAY63-2521)