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NCT01516541 · ClinicalTrials.gov registry record · Phase 3

A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease

A Phase 3 study of Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD), sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
2,220
Enrollment target
20
Study locations

NCT01516541 is a Phase 3 study of Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD) that has completed, run by Hoffmann-La Roche. The registered enrollment target is 2,220 participants. The trial reports 20 study locations across 5 states.

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The verdict

NCT01516541, a Phase 3 study of Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD), has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
2,220 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)

Interventions

  • DRUG Placebo
  • OTHER Background care
  • DRUG dalcetrapib

Study Locations (20)

California

  • - Anaheim
  • - Fullerton
  • - San Diego
  • - Santa Ana
  • - Santa Rosa
  • - Torrance
  • - Torrance

Florida

  • - Boynton Beach
  • - Daytona Beach
  • - Daytona Beach
  • - Fort Myers
  • - Jacksonville
  • - Panama City

Colorado

  • - Colorado Springs
  • - Denver
  • - Lonetree

Alabama

  • - Birmingham
  • - Huntsville

Connecticut

  • - Bridgeport
  • - Hartford

Trial Details

FieldValue
Enrollment Target 2,220 participants
Start Date 2012-01
Est. Completion 2012-07
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01516541

The ClinicalTrials.gov registry entry for NCT01516541 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01516541 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Colorado.

Frequently Asked Questions

What is clinical trial NCT01516541 about?

NCT01516541 is a clinical study titled "A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease". 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 dise...

What is the current status of trial NCT01516541?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,220 participants. The study started on 2012-01. Estimated completion is 2012-07.

What conditions does trial NCT01516541 study?

This clinical trial studies the following conditions: Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD).

What interventions are being tested in trial NCT01516541?

The interventions under investigation include: Placebo (DRUG), Background care (OTHER), dalcetrapib (DRUG).

Who is sponsoring clinical trial NCT01516541?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01516541 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.