Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg

A 6wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel Group Study to Compare the Safety & Efficacy of Rosuvastatin 40mg in Comb.With Ezetimibe 10mg in Subjects With Hypercholesterolaemia & CHD or Atherosclerosis or a CHD Risk Equiv. (10 yr Risk Score >20%).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00653445

Acronym

EXPLORER

Enrollment

Unknown

Registered

2008-04-07

Start date

2004-06-30

Completion date

2005-06-30

Last updated

2009-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Coronary Heart Disease, Hypercholesterolemia

Keywords

Low density lipoproteins, Hypercholesterolemia, Coronary Heart Disease, Rosuvastatin, Crestor, Ezetimibe

Brief summary

The purpose of this study is to compare 6 weeks of treatment with rosuvastatin alone compared with 6 weeks of treatment of rosuvastatin combined with ezetimibe in achieving low density lipoprotein level goals.

Interventions

DRUGRosuvastatin

40mg

DRUGEzetimibe

10mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* A history of CHD or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol. * Fasting LDL-C concentrations at Visit 1 as defined in the protocol. * Discontinuation of all lipid lowering therapy at Visit 1.

Exclusion criteria

* History of statin induced serious side effects, or serious hypersensitivity reaction to other statins. * Subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (TIA) or stroke. * Severe congestive cardiac failure (as defined by the protocol - Appendix I). * Subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1)..

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting low-density lipoprotein cholesterol (LDL-C) levels at baseline and Week 6	—

Secondary

Measure	Time frame
To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting blood lipid levels levels at baseline and Week 6	—
Safety: by measuring adverse events & abnormal laboratory markers to compare safety & tolerability of rosuvastatin alone with rosuvastatin combined with ezetimibe	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026