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

Hypertension, Pulmonary Clinical Trial

— RIALTO  

Official title:

An Open-label, Multi-national, Multi-center, Single-arm, Uncontrolled, Long-term Extension Study of Orally Administered Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) Who Received Riociguat in a Bayer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02759419
• Other study ID #: 18694
• Secondary ID: 2016-000501-36
• Status: Recruiting
• Phase: Phase 4
• Start date: June 16, 2016
• Est. completion date: December 28, 2025

Study information

• Verified date: May 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-8422937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 28, 2025
• Est. primary completion date: December 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Adempas (Riociguat, BAY63-2521)
0.5 to 2.5 mg in 0.5 mg increments (according to individual adapted optimal dose determined in originating study) administered three times daily (tid)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

France,  Italy,  Korea, Republic of,  Poland,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with treatment-emergent adverse events (TEAEs) as measure of safety and tolerability		Up to approx. 3 years

External Links

•   Click here to find further information and, after study completion, the study results according to Bayer's transparency standards