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Trial record 1 of 1 for:    NCT02759419
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A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension. (RIALTO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02759419
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : February 3, 2021
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Drug: Adempas (Riociguat, BAY63-2521) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : June 16, 2016
Estimated Primary Completion Date : December 28, 2023
Estimated Study Completion Date : December 28, 2023

Arm Intervention/treatment
Experimental: BAY63-2521
Single-arm, uncontrolled
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)

Primary Outcome Measures :
  1. Number of patients with treatment-emergent adverse events (TEAEs) as measure of safety and tolerability [ Time Frame: Up to approx. 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02759419

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Contact: Bayer Clinical Trials Contact (+)1-888-8422937

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Besancon, France, 25030
Brest, France, F-29609
Le Kremlin Bicetre Cedex, France, 94275
Lille Cedex, France, 59037
Rouen, France, 76031
Roma, Lazio, Italy, 00161
Pavia, Lombardia, Italy, 27100
Korea, Republic of
Seoul, Korea, Republic of, 03080
Seoul, Korea, Republic of, 03722
Seoul, Korea, Republic of, 05505
Seoul, Korea, Republic of, 06351
Krakow, Poland, 31-202
Lodz, Poland, 91-347
Otwock, Poland, 05-400
Wroclaw, Poland, 51-124
Bangkok, Thailand, 10330
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer Identifier: NCT02759419    
Other Study ID Numbers: 18694
2016-000501-36 ( EudraCT Number )
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Enzyme Activators
Molecular Mechanisms of Pharmacological Action