A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension. (RIALTO)

Bayer

Status and phase

Enrolling

Phase 4

Conditions

Hypertension, Pulmonary

Treatments

Drug: Adempas (Riociguat, BAY63-2521)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02759419

2016-000501-36 (EudraCT Number)

18694

Details and patient eligibility

About

To provide riociguat therapy to eligible patients with PAH originating from Bayer-sponsored trials with BAY63-2521/ Riociguat / Adempas® who are currently or recently treated in these trials until lack of patient benefit as assessed by investigator, or commercial availability and reimbursement.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients diagnosed with Pulmonary Arterial Hypertension (PAH) participating or having participated in the Bayer-sponsored studies 12935, 16719 or 18588, who have completed the main study phase and are still being treated with riociguat (either while still being on treatment with the respective study drug or by commercial means with Adempas) and who, in the opinion of the investigator, are expected to continue to have an overall positive benefit/risk from continuing treatment.
Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and 30 days after the last administration of study drug.

Exclusion criteria

Ongoing serious adverse event (SAE) from originating study that is assessed as related to riociguat
Pregnant women or breast-feeding women
Any contra-indication to Adempas treatment listed in the BAY63-2521 / Riociguat Investigators's Brochure
Concomitant participation in another clinical study with the study drug
Patients with pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)