MedTrace Logo

12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe

NCT00525824 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1743

Last updated 2011-05-13

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine whether treatment of Rosuvastatin (CRESTOR™) or Simvastatin given as monotherapy or given in combination with Ezetimibe, will lower the Low Density Lipoprotein Cholesterol (LDL-C) in patients with Hypercholesterolaemia and Coronary Heart Disease (CHD) or a CHD Risk Equivalent, Atherosclerosis or a 10-year CHD Risk of \>20%

Conditions

Interventions

DRUG

Rosuvastatin (Crestor)

10mg and 20 mg

DRUG

Ezetimibe

10 mg

DRUG

Simvastatin

40mg and 80 mg

Sponsors & Collaborators

Principal Investigators

  • Christie M Ballantyne, MD FACP FACC · Centre for Cardiovascular Disease Prevention

  • Margareta Grind, MD PhD FFPM · Medicine and Sciences AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States
  • Argentina
  • Brazil
  • Chile
  • Colombia
  • Lithuania
  • Netherlands
  • Peru
  • Venezuela

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 NCT00525824 on ClinicalTrials.gov