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Therapeutic Areas: Cardiology/Vascular Diseases | Genetic Disease | Family Medicine
Disease Category: Coronary Artery Disease
Location: United States, PA

Clinical Trial Details

Overview

Research Study Summary

A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients With Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD).

Purpose

This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated risk for cardiovascular disease. Eligible patients will be randomized to receive either dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary, guidelines-based medical care. Anticipated time on study treatment is 4 years.

Patient Inclusion Criteria:

  • Adult patients, ≥ 45 years of age
  • Established cardiovascular disease A stable coronary disease B cerebrovascular disease C peripheral artery disease
  • Without established coronary disease D pharmacologically treated type 2 diabetes mellitus and one or more risk factor(s) for cardiovascular disease E 3 or more risk factors for cardiovascular disease
  • Receiving evidence-based medical and dietary management of dyslipidemia
  • Patient Exclusion Criteria:

    • Occurrence of myocardial infarction, hospitalization for unstable angina, stroke or revascularization (coronary, carotid or peripheral) within three months prior to randomization
    • Uncontrolled hypertension
    • Uncontrolled diabetes
    • Concomitant treatment with any other drug raising HDL-C
    • Previous treatment with compounds targeting CETP

    To Learn more
Phase

3

Gender

Both Male and Female

Age

45 and up

Overall Status

Recruiting

Duration

4 Years

Facility Type

N/A

Contact

Julia Benton, RN, CCRC, site manager
Blair Medical Associates, Inc. Clinical Trials Dept.
Blair Medical Associates, Inc. Station Medical Center
1414 Ninth Ave.
Altoona, PA 16602
Phone: 814-946-7569
Fax: 814-949-1966

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 180488

Date Last Changed: July 19, 2013


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