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ApoA-I Synthesis Stimulation and Intravascular Ultrasound for Coronary Atheroma Regression Evaluation

NCT01067820 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2013-06-04

No results posted yet for this study

Summary

This study is designed to characterize the early effects of ApoA-I synthesis with RVX000222 on coronary atherosclerotic disease when administered to patients with coronary artery disease and have a low HDL-C level, as assessed by Intravascular Ultrasound (IVUS) in addition to standard background therapy.

Conditions

Interventions

DRUG

RVX000222

capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 26 weeks

DRUG

Placebo RVX000222

capsule, administer with food, twice daily 10-12 hrs apart, 26 weeks

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Resverlogix Corp

    lead INDUSTRY

Principal Investigators

  • Stephen Nicholls, MBBS, PhD · Intravascular Ultrasound Core Lab, Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-05-31
Completion
2013-06-30

Countries

  • Argentina
  • Belgium
  • Brazil
  • Hungary
  • Netherlands
  • Poland
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT01067820 on ClinicalTrials.gov