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MDCO-216 Infusions Leading to Changes in Atherosclerosis: A Novel Therapy in Development to Improve Cardiovascular Outcomes - Proof of Concept Intravascular Ultrasound (IVUS), Lipids, and Other Surrogate Biomarkers Trial

NCT02678923 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2017-07-13

Study results available
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Summary

This study will be a proof-of-concept, placebo-controlled, double-blind, randomized trial in participants with a recent acute coronary syndrome (ACS) to evaluate the efficacy, pharmacokinetics, safety, tolerability, disease progression measures by IVUS, and pharmacodynamics of MDCO-216 infusion. Eligible participants will be randomized to receive 5 infusions of MDCO-216 20 milligrams/kilogram (mg/kg) or placebo in a 1:1 ratio.

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

MDCO-216

DRUG

Placebo

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • The Medicines Company

    lead INDUSTRY

Principal Investigators

  • Stephen Nicholls, MBSS, PhD · South Australian Health & Medical Research Institute (SAHMRI) in Adelaide, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-03
Primary Completion
2016-10-26
Completion
2016-10-26
FDA Drug
Yes

Countries

  • Canada
  • Czechia
  • Hungary
  • Netherlands
  • Poland

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 NCT02678923 on ClinicalTrials.gov