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Study of Heart and Renal Protection

NCT00125593 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9438

Last updated 2012-02-01

Study results available
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Summary

The chief aim of SHARP was to determine whether lowering blood LDL cholesterol with simvastatin (20mg) plus ezetimibe (10mg) daily could safely reduce the risk of coronary heart disease, non-hemorrhagic stroke and the need for revascularization procedures in patients with chronic kidney disease (CKD). It also aimed to assess whether lowering LDL cholesterol reduced the rate of loss of renal function in people with CKD who had not commenced dialysis treatment.

Conditions

  • Kidney Disease, Chronic

Interventions

DRUG

Simvastatin 20 mg

Once daily

DRUG

Ezetimibe 10mg

Once daily

DRUG

Placebo

Once daily

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Schering-Plough

    collaborator INDUSTRY

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • British Heart Foundation

    collaborator OTHER

  • Medical Research Council

    collaborator OTHER_GOV

  • University of Oxford

    lead OTHER

Principal Investigators

  • Colin Baigent, FRCP, FFPH · Clinical Trial Service Unit & Epidemiological Studies Unit, University of Oxford

  • Martin J Landray, PhD, FRCP · Clinical Trial Service Unit & Epidemiological Studies Unit, University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT00125593 on ClinicalTrials.gov