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Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE

NCT00461630 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25673

Last updated 2014-02-28

Study results available
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Summary

The primary aim is to assess the effects of raising HDL cholesterol (the good type) with extended release niacin/laropiprant 2g (previously known as MK-0524A) versus matching placebo on the risk of heart attack or coronary death, stroke, or the need for arterial bypass procedures (revascularisation) in people with a history of circulatory problems. The secondary aim is to assess the effects of extended release niacin/laropiprant 2g daily on heart attack, coronary death, stroke, and revascularisation separately and to assess the effects on mortality both overall and in various categories of causes of death, and of the effects on major cardiovascular events in people with a history of different diseases at the beginning of the study.

Conditions

Interventions

DRUG

ER niacin/laropiprant

DRUG

simvastatin

40 mg simvastatin tablet orally per day as background LDL-lowering treatment allocated at entry based on previous statin treatment and total cholesterol level

DRUG

ezetimibe/simvastatin

10 mg ezetimibe plus 40 mg simvastatin in single tablet taken once daily as background LDL-lowering treatment allocated at entry based on previous statin treatment and total cholesterol level

Sponsors & Collaborators

Principal Investigators

  • Jane Armitage · Clinical Trial Service Unit, University of Oxford

  • Colin Baigent · Clinical Trial service Unit, University of Oxford

  • Zhengming Chen · Clinical Trial Service Unit, University of Oxford

  • Martin Landray · Clinical Trial Service Unit, University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00461630 on ClinicalTrials.gov