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OpenTrials
Completed

NCT Number: NCT02759419

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

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.

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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Adempas (Riociguat, BAY63-2521)

Drug

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)

Primary outcomes

  1. Number of patients with treatment-emergent adverse events (TEAEs) as measure of safety and tolerability

    Time frame: Up to approx. 3 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: RIALTO

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
May 3, 2016
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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