Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (EAS)

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Bayer

Status

Conditions

Hypertension, Pulmonary

Treatments

Drug: Adempas (Riociguat, BAY63-2521)

Study type

Expanded Access

Funder types

Industry

Identifiers

NCT01784562
2012-002104-40 (EudraCT Number)
16097

Details and patient eligibility

About

The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.

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 other than Dana Point Classification Group 4
  • Operable patients listed for PEA (Pulmonary Endarterectomy)

Trial contacts and locations

102

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Data sourced from clinicaltrials.gov

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