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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.
 
ClinicalTrials.gov Identifier: NCT02759419
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

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
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, 2021
Estimated Study Completion Date : December 28, 2021


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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02759419


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-8422937 clinical-trials-contact@bayer.com

Locations
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France
Recruiting
Besancon, France, 25030
Recruiting
Brest, France, F-29609
Recruiting
Le Kremlin Bicetre Cedex, France, 94275
Recruiting
Lille Cedex, France, 59037
Completed
Rouen, France, 76031
Italy
Withdrawn
Roma, Lazio, Italy, 00161
Withdrawn
Pavia, Lombardia, Italy, 27100
Korea, Republic of
Recruiting
Seoul, Korea, Republic of, 03080
Recruiting
Seoul, Korea, Republic of, 03722
Recruiting
Seoul, Korea, Republic of, 05505
Recruiting
Seoul, Korea, Republic of, 06351
Poland
Withdrawn
Krakow, Poland, 31-202
Withdrawn
Lodz, Poland, 91-347
Withdrawn
Otwock, Poland, 05-400
Withdrawn
Wroclaw, Poland, 51-124
Thailand
Withdrawn
Bangkok, Thailand, 10330
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02759419    
Other Study ID Numbers: 18694
2016-000501-36 ( EudraCT Number )
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

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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
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Riociguat
Enzyme Activators
Molecular Mechanisms of Pharmacological Action