stop_circleTerminated/Withdrawn
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Bayer Identifier:
14554
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A study to test the effects of Riociguat in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction
Trial purpose
The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction
Key Participants Requirements
Sex
BothAge
18 - 90 YearsTrial summary
Enrollment Goal
39Trial Dates
July 2010 - October 2012Phase
Phase 2Could I Receive a placebo
YesProducts
Adempas (Riociguat, BAY63-2521)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Krankenhaus der Elisabethinen Linz | Linz, 4010, Austria |
Completed | Landeskrankenhaus Salzburg | Salzburg, 5020, Austria |
Completed | Allgemeines Krankenhaus der Stadt Wien Universitätskliniken | Wien, 1090, Austria |
Terminated | LKH Graz West | Graz, 8020, Austria |
Terminated | Medizinische Universität Graz | Graz, 8036, Austria |
Completed | Vseobecna fakultni nemocnice | Praha 2, 12808, Czech Republic |
Completed | Universitätsklinikum Köln | Köln, 50924, Germany |
Primary Outcome
- Pulmonary artery mean pressure at restdate_rangeTime Frame:Peak change from baseline within 6 hours after a single dose of study drugenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Adverse event collectiondate_rangeTime Frame:until 30 days after study drug treatmentenhanced_encryptionYesSafety Issue:
- Plasma concentrations to obtain pharmacokinetic profile of Riociguatdate_rangeTime Frame:Within 24 hours after study drug treatmentenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
4Additional Information
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