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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 September 2024 |
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Main ID: |
NCT02759419 |
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Date of registration:
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29/04/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension.
RIALTO |
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Scientific title:
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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 |
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Date of first enrolment:
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June 16, 2016 |
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Target sample size:
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25 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02759419 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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France
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Italy
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Korea, Republic of
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Poland
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Thailand
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Contacts
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Name:
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Bayer Clinical Trials Contact |
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Address:
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Telephone:
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(+)1-888-8422937 |
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Email:
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clinical-trials-contact@bayer.com |
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Affiliation:
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypertension, Pulmonary
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Intervention(s)
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Drug: Adempas (Riociguat, BAY63-2521)
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Primary Outcome(s)
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Number of patients with treatment-emergent adverse events (TEAEs) as measure of safety and tolerability
[Time Frame: Up to approx. 3 years]
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Secondary ID(s)
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18694
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2016-000501-36
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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