check_circleStudy Completed

Heart Failure

A single-blind pilot study to investigate safety and tolerability of the chymase inhibitor BAY1142524 in clinically stable patients with left-ventricular dysfunction

Trial purpose

The purpose of the trial is the analysis of safety and tolerability of the chymase inhibitor BAY1142524 in comparison to placebo using a 2 weeks treatment period in clinically stable patients with left-ventricular dysfunction after myocardial infarction. BAY1142524 or placebo will be given on top of evidence-based standard of care for left-ventricular dysfunction after myocardial infarction. Primary objectives are the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. BAY1142524 will be administered in a parallel group design using four doses (5, 10, 25 mg twice daily, and 50 mg once daily). Each dose group consists of 9 patients treated with verum and 3 patients treated with placebo.

Key Participants Requirements

Sex

Both

Age

40 - 79 Years

Trial summary

Enrollment Goal
49
Trial Dates
July 2015 - March 2016
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Fulacimstat (BAY1142524)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Berlin, 13353, Germany
Completed
Frankfurt, 60594, Germany
Completed
Erfurt, 99084, Germany
Terminated
Düsseldorf, 40225, Germany
Completed
Bergamo, 24127, Italy
Completed
Brescia, 25123, Italy
Completed
Copenhagen Ø, 2100, Denmark
Completed
Hellerup, 2900, Denmark
Completed
Copenhagen, DK-2400, Denmark
Completed
Herlev, 2730, Denmark

Primary Outcome

  • Number of participants with adverse events
    date_rangeTime Frame:
    Up to 20 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with serious adverse events
    date_rangeTime Frame:
    Up to 20 days
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A single-blind, multicenter pilot study to investigate the safety and tolerability of a 14 day oral treatment with different doses of the chymase inhibitor BAY1142524 in comparison to placebo in clinically stable patients with left-ventricular dysfunction after myocardial infarction
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
4