Completed

CDR132L Safety, PK and PD Assessment in Stable Ischemic Heart Failure Patients (NYHA 1-3)

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Study Aim

This study aims to evaluate the safety and tolerability of CDR132L in patients with stable ischemic heart failure (NYHA 1-3) by assessing the incidence and severity of treatment-emergent adverse events.

What is being tested

CDR132L

Drug
Who is being recruted

Cardiovascular Diseases

+ Heart Diseases

+ Heart Failure

From 18 to 80 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1
Interventional
Study Start: June 2019
See protocol details

Summary

Principal SponsorCardior Pharmaceuticals GmbH
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 21, 2019

Actual date on which the first participant was enrolled.

This is a study about a drug called CDR132L, which is being tested in people with stable heart failure caused by ischemic heart disease. The heart failure is classified as NYHA 1-3, which means it ranges from mild to moderate. The main goal of this study is to see if CDR132L is safe for these patients. It's important because it could potentially help manage heart failure better and improve patients' quality of life. In this study, participants will receive either a single dose or repeated doses of CDR132L, or a placebo (a substance with no therapeutic effect). The study will look at how the body processes the drug, known as its pharmacokinetic (PK) profile. It will also explore how the drug affects the body, referred to as its pharmacodynamic (PD) parameters. The primary outcome measured will be any adverse events that occur during the treatment, which helps to understand the safety and tolerability of CDR132L.

Official TitlePhase I, Randomized, Double-blind, Placebo-controlled Study to Assess Safety, PK and PD Parameters of CDR132L in Patients With Stable Heart Failure of Ischemic Origin (NYHA 1- 3)
NCT04045405
Principal SponsorCardior Pharmaceuticals GmbH
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart Failure

Criteria

1 inclusion criteria required to participate
Stable heart failure of ischemic origin
1 exclusion criteria prevent from participating
Heart failure of non-ischemic origin (hypertensive heart disease, myocarditis, alcoholic cardiomyopathy and cardiac dysfunction due to rapid atrial fibrillation),

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Richmond Pharmacology Ltd., 1A Newcomen Street, London Bridge

London, United KingdomOpen Richmond Pharmacology Ltd., 1A Newcomen Street, London Bridge in Google Maps
CompletedOne Study Center