stop_circleTerminated/Withdrawn

Hypertension, Pulmonary, Ventricular Dysfunction, Left

Bayer Identifier:

14554

ClinicalTrials.gov Identifier:

NCT01172756

EudraCT Number:

2010-018436-41

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

Both

Age

18 - 90 Years
  • - Male and female patients with symptomatic pulmonary hypertension due to left ventricular diastolic dysfunction
  • - Types of pulmonary hypertension other than group 2.2 of Dana Point Classification

Trial summary

Enrollment Goal
39
Trial Dates
July 2010 - October 2012
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Krankenhaus der Elisabethinen LinzLinz, 4010, Austria
Completed
Landeskrankenhaus SalzburgSalzburg, 5020, Austria
Completed
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Terminated
LKH Graz WestGraz, 8020, Austria
Terminated
Medizinische Universität GrazGraz, 8036, Austria
Completed
Vseobecna fakultni nemocnicePraha 2, 12808, Czech Republic
Completed
Universitätsklinikum KölnKöln, 50924, Germany

Primary Outcome

  • Pulmonary artery mean pressure at rest
    date_rangeTime Frame:
    Peak change from baseline within 6 hours after a single dose of study drug
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Adverse event collection
    date_rangeTime Frame:
    until 30 days after study drug treatment
    enhanced_encryption
    Safety Issue:
    Yes
  • Plasma concentrations to obtain pharmacokinetic profile of Riociguat
    date_rangeTime Frame:
    Within 24 hours after study drug treatment
    enhanced_encryption
    Safety Issue:
    No

Trial design

Acute hemodynamic effects of Riociguat (BAY63-2521) in patients with pulmonary hypertension associated with diastolic heart failure: A randomized, double-blind, placebo-controlled, single-dose study in three ascending dose cohorts
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

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