Trial Condition(s):
Hypertension, Pulmonary
A long-term extension study of riociguat in patients with symptomatic pulmonary arterial hypertension. (RIALTO)
Bayer Identifier:
18694
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Lille Cedex, France, 59037 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-8422937 |
Locations Investigative Site BREST, France, F-29609 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-8422937 |
Locations Investigative Site Rouen, France, 76031 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-8422937 |
Locations Investigative Site BESANCON, France, 25030 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-8422937 |
Locations Investigative Site LE KREMLIN BICETRE CEDEX, France, 94275 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-8422937 |
Locations Investigative Site Seoul, South Korea, 3722 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-8422937 |
Locations Investigative Site Seoul, South Korea, 3080 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-8422937 |
Locations Investigative Site Seoul, South Korea, 6351 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-8422937 |
Locations Investigative Site Seoul, South Korea, 138-736 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-8422937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Number of patients with treatment-emergent adverse events (TEAEs) as measure of safety and tolerabilityTimeframe: Up to approx. 3 years
Additional Information
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