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Completed

NCT Number: NCT00525824

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

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%

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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

Primary location

Research Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with with hypercholesterolaemia and CHD or a CHD risk equivalent, clinical evidence of atherosclerosis or a Framingham 10-year CHD risk score of >20
  • Patients will need to sign an informed consent before any visit procedures can be performed, including procedures for the optional genetic research and biomarker studies.
  • Patients must be 18 years or older and will be asked to stop taking any current cholesterol-lowering medications. Dietary counselling will be provided which will include an overview of the Therapeutic Lifestyle Change (TLC) diet the patients will be asked to follow

Exclusion criteria

  • Use of lipid lowering drugs and other prohibited concomitant medications. History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin, simvastatin and/or a history of hypersensitivity to any components of ezetimibe.
  • Patients considered to be unstable by their physician after the following events:

a myocardial infarction, recent episode of unstable angina, myocardial revascularisation [percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) surgery or another revascularisation procedure] or a transient ischaemic attack (TIA) or stroke and patients awaiting a planned myocardial revascularisation

Treatment and study plan

Rosuvastatin (Crestor)

Drug

10mg and 20 mg

ezetimibe

Drug

10 mg

simvastatin

Drug

40mg and 80 mg

Primary outcomes

  1. Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment

    Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

    Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value*100

Secondary outcomes

  1. Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment

    Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

    Percent change in HDL-C = (Combination treatment value - Baseline value)/Baseline value*100

  2. Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment

    Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

    Percent change in TC = (Combination treatment value - Baseline value)/Baseline value*100

  3. Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment

    Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

    Percent change in TG = (Combination treatment value - Baseline value)/Baseline value*100

  4. Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment

    Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

    Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value*100

  5. Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment

    Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

    Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value*100

  6. Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment

    Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

    Percent change in ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100

  7. Percent Change in TC/HDL-C After 6 Weeks Combination Treatment

    Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

    Percent change in TC/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100

  8. Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment

    Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

    Percent change in LDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100

  9. Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment

    Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

    Percent change in non-HDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100

  10. Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment

    Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

    Percent change in ApoB/ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100

  11. Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment

    Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

    Percent change in hs-CRP = (Combination treatment value - Baseline value)/Baseline value*100

  12. Percent Change in LDL-C After 6 Weeks Monotherapy

    Time frame: Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward)

    Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value*100

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 12-week Open-label, Randomised, Parallel-group, Multicentre, Phase IIIb Study to Compare the Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe and Simvastatin in Patients With Hypercholesterolaemia and CHD

Acronym: GRAVITY

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 6, 2007
Registry last updated
May 13, 2011

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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