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

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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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

BAY63-2521
Experimental group
Description:
Single-arm, uncontrolled
Treatment:
Drug: Adempas (Riociguat, BAY63-2521)

Trial contacts and locations

16

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Central trial contact

Bayer Clinical Trials Contact

Data sourced from clinicaltrials.gov

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