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Pharmacodynamic Effects of Riociguat in Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction

NCT02744339 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2020-11-04

No results posted yet for this study

Summary

The primary objective of this study is to

• Assess the pharmacodynamic profile of riociguat in subjects with symptomatic pulmonary hypertension and heart failure with preserved ejection fraction

The secondary objectives of this study are to

* Assess safety and tolerability of riociguat in this study population
* Assess changes in dimensions of left and right ventricles and cardiac function parameters using cardiac magnetic resonance imaging

Conditions

  • Hypertension, Pulmonary
  • Heart Failure With Normal Ejection Fraction

Interventions

DRUG

Riociguat

Adempas up-titrated to max. 1.5mg TID

DRUG

Placebo

Placebo sham-titrated TID

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Diana Bonderman, MD · Medical University of Vienna

  • Johannes Kastner, MD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-08-31
Completion
2020-09-30

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02744339 on ClinicalTrials.gov