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OpenTrials
Completed

NCT Number: NCT00653445

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

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.

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Key information

Conditions

Hypercholesterolemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Coronary Disease Coronary Heart Disease Dyslipidemias Heart Diseases Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)..

Treatment and study plan

Rosuvastatin

Drug

40mg

Other names: Crestor

ezetimibe

Drug

10mg

Other names: Zetia

Primary outcomes

  1. 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 outcomes

  1. To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting blood lipid levels levels at baseline and Week 6

  2. Safety: by measuring adverse events & abnormal laboratory markers to compare safety & tolerability of rosuvastatin alone with rosuvastatin combined with ezetimibe

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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%).

Acronym: EXPLORER

Important dates

Study start
2004
Study completion
2005
First posted
Apr 7, 2008
Registry last updated
Mar 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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