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CER-001 Atherosclerosis Regression ACS Trial

NCT02484378 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2019-02-11

No results posted yet for this study

Summary

The purpose of this study is to assess the impact of ten intravenous infusions of 3 mg/kg CER 001 vs. placebo, given at weekly intervals for ten weeks, on atherosclerotic plaque volume as measured by coronary IVUS, when administered to subjects presenting with Acute Coronary Syndrome (ACS) with significant plaque volume.

Conditions

  • Acute Coronary Syndromes

Interventions

DRUG

CER-001

Engineered pre-beta HDL particle

DRUG

Placebo

Normal saline

Sponsors & Collaborators

  • South Australian Health and Medical Research Institute

    collaborator OTHER

  • Cerenis Therapeutics, SA

    lead INDUSTRY

Principal Investigators

  • Connie Keyserling, MS · Cerenis Therapeutics

  • Stephen Nicholls, MD PhD · South Australian Health and Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-11-30
Completion
2016-12-31

Countries

  • United States
  • Australia
  • Hungary
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

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 NCT02484378 on ClinicalTrials.gov