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NCT02976467: CHIARA MIA 2

A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY 1142524 in Patients After Acute Myocardial Infarction With Left-ventricular Dysfunction

Completed Phase 2 Last updated 3 September 2019
What this trial tests

Phase 2 trial testing Fulacimstat (BAY1142524) in Myocardial Infarction in 107 participants. Completed in 4 September 2018.

Timeline
30 December 2016
Primary endpoint
31 July 2018
4 September 2018

Quick facts

Lead sponsorBayer
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment107
Start date30 December 2016
Primary completion31 July 2018
Estimated completion4 September 2018
Sites25 locations across Italy, Israel, Germany, Spain, Czechia

Drugs / interventions tested

Conditions studied

Sponsor

Bayer — full company profile →

Who can join

Adults 40 to 79, any sex, with Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in patients with left-ventricular (LV) dysfunction after myocardial infarction (MI). BAY1142524 or placebo will be given on top of evidence-based standard of care for left-ventricular dysfunction after myocardial infarction. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in functional parameters of adverse cardiac remodelling (i.e. endsystolic and enddiastolic volume index, ejection fraction). Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 30 patients have to complete treatment with verum and 30 patients have to complete treatment with placebo.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A novel hamster nonalcoholic steatohepatitis model induced by a high-fat and high-cholesterol diet.
    Miyaoka Y, Jin D, Tashiro K, Masubuchi S, et al · · 2018 · cited 10× · PMID 29311502 · DOI 10.1538/expanim.17-0126
  2. A Chymase Inhibitory RNA Aptamer Improves Cardiac Function and Survival after Myocardial Infarction.
    Jin D, Takai S, Nonaka Y, Yamazaki S, et al · · 2019 · cited 9× · PMID 30572223 · DOI 10.1016/j.omtn.2018.11.001

Verify or expand the search:

Other trials of Fulacimstat (BAY1142524)

Trials testing the same drug.

Other recruiting trials for Myocardial Infarction

Currently open trials in the same condition.

Other Bayer trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02976467.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing