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A Single-blind Pilot Study to Investigate Safety and Tolerability of the Chymase Inhibitor BAY1142524 in Clinically Stable Patients With Left-ventricular Dysfunction

NCT02452515 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2017-11-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

BAY1142524

5 mg BAY1142524 or placebo given as 5 mg IR tablet twice daily for 2 weeks

DRUG

BAY1142524

10 mg BAY1142524 or placebo given as 2 x 5 mg IR tablets twice daily as for 2 weeks

DRUG

BAY1142524

25 mg BAY1142524 or placebo given as 5 x 5 mg IR tablets twice daily for 2 weeks

DRUG

BAY1142524

50 mg BAY1142524 or placebo given 1 x 50 mg IR tablet once daily for 2 weeks

DRUG

Placebo

The patients will be treated orally with combinations of IR tablets containing placebo to achieve the indicated dosages.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • Denmark
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT02452515 on ClinicalTrials.gov