Back to resultsA Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension. (RIALTO)
Primary Purpose
Hypertension, Pulmonary
Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Adempas (Riociguat, BAY63-2521)
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension, Pulmonary
Eligibility 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)
Sites / Locations
- Recruiting
- Recruiting
- Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BAY63-2521
Arm Description
Single-arm, uncontrolled
Outcomes
Primary Outcome Measures
Number of patients with treatment-emergent adverse events (TEAEs) as measure of safety and tolerability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02759419
Brief Title
A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension.
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2016 (Actual)
Primary Completion Date
December 28, 2025 (Anticipated)
Study Completion Date
December 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BAY63-2521
Arm Type
Experimental
Arm Description
Single-arm, uncontrolled
Intervention Type
Drug
Intervention Name(s)
Adempas (Riociguat, BAY63-2521)
Intervention Description
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 Measure Information:
Title
Number of patients with treatment-emergent adverse events (TEAEs) as measure of safety and tolerability
Time Frame
Up to approx. 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bayer Clinical Trials Contact
Phone
(+)1-888-8422937
Email
clinical-trials-contact@bayer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Besancon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Completed
City
Brest
ZIP/Postal Code
F-29609
Country
France
Individual Site Status
Completed
City
Le Kremlin Bicetre Cedex
ZIP/Postal Code
94275
Country
France
Individual Site Status
Completed
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Completed
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Completed
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Withdrawn
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Withdrawn
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Completed
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Individual Site Status
Recruiting
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Individual Site Status
Withdrawn
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Individual Site Status
Withdrawn
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Withdrawn
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Individual Site Status
Withdrawn
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Withdrawn
12. IPD Sharing Statement
Learn more about this trial
A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension.
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