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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05350969
Other study ID # CDR132L-P2-01
Secondary ID 2021-006040-27
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date June 27, 2022
Est. completion date March 11, 2025

Study information

Verified date March 2024
Source Cardior Pharmaceuticals GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 2, multicenter, randomized, parallel, 3-arm, placebo-controlled study to assess efficacy and safety of CDR132L in patients with reduced Left Ventricular Ejection Fraction (LVEF) (≤ 45%) after myocardial infarction (MI). This study consists of a screening period (to occur at least 3 days after MI diagnosis), a 6-month double-blind period, and a 6-month extension period with the End of Study (EOS) Visit at Day 360/Month 12. Two dosages of CDR132L will be tested against placebo on their effects on patients, who just had a heart attack in addition to standard care. The aim of the study is to show that CDR132L is safe and effective to improve heart failure in such patients.


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Study Design


Intervention

Drug:
CDR132L
CDR132L is a synthetic antisense oligonucleotide (ASO) and a selective inhibitor of microRNA-132-3p (miR-132). miR-132 in cardiomyocytes is a central switch affecting the expression of genes that are crucially involved in maladaptive cardiac remodeling, transformation, and pathological cardiac growth (hypertrophy), contributing to adverse cardiac remodeling and heart failure (HF).1-5 Aberrant expression of miR-132 in cardiac cells is causally associated with cardiac remodeling and HF progression.
Placebo to CDR132L
Placebo to CDR132L

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Sponsors (1)

Lead Sponsor Collaborator
Cardior Pharmaceuticals GmbH

Countries where clinical trial is conducted

Czechia,  Germany,  Greece,  Hungary,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Echocardiography (ECHO) Percent change from baseline (screening to occur at least 3 days after MI diagnosis as measured by ECHO [central laboratory]) in Left Ventricular End-Systolic Volume (LVESVI) at Month 6. 6 months
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