12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe (GRAVITY)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00525824
First received: September 5, 2007
Last updated: May 11, 2011
Last verified: May 2011
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Purpose
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%
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia Coronary Heart Disease Atherosclerosis |
Drug: Rosuvastatin (Crestor) Drug: Ezetimibe Drug: Simvastatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Secondary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]Percent change in HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
- 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) ] [ Designated as safety issue: No ]Percent change in TC = (Combination treatment value - Baseline value)/Baseline value*100
- 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) ] [ Designated as safety issue: No ]Percent change in TG = (Combination treatment value - Baseline value)/Baseline value*100
- 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) ] [ Designated as safety issue: No ]Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value*100
- 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) ] [ Designated as safety issue: No ]Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value*100
- 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) ] [ Designated as safety issue: No ]Percent change in ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100
- 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) ] [ Designated as safety issue: No ]Percent change in TC/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
- 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) ] [ Designated as safety issue: No ]Percent change in LDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
- 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) ] [ Designated as safety issue: No ]Percent change in non-HDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
- 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) ] [ Designated as safety issue: No ]Percent change in ApoB/ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100
- 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) ] [ Designated as safety issue: No ]Percent change in hs-CRP = (Combination treatment value - Baseline value)/Baseline value*100
- Percent Change in LDL-C After 6 Weeks Monotherapy [ Time Frame: Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward) ] [ Designated as safety issue: No ]Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value*100
| Enrollment: | 1743 |
| Study Start Date: | August 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Rosuvastatin (Crestor)
10mg and 20 mg
Drug: Ezetimibe
10 mg
Drug: Simvastatin
40mg and 80 mg
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525824
Locations
| United States, Tennessee | |
| Research Site | |
| Brentwood, Tennessee, United States | |
| Argentina | |
| Research Site | |
| Buenos Aires, Argentina | |
| Brazil | |
| Research Site | |
| Sao Paulo, SP, Brazil | |
| Chile | |
| Research Site | |
| Santiago, Chile | |
| Colombia | |
| Research Site | |
| Brentwood, Colombia | |
| Lithuania | |
| Research Site | |
| Brentwood, Lithuania | |
| Netherlands | |
| Research Site | |
| Zwinderen, Netherlands | |
| Peru | |
| Research Site | |
| Lima, San Isidro Lima, Peru | |
| Venezuela | |
| Research Site | |
| Brentwood, Venezuela | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Christie M Ballantyne, MD FACP FACC | Centre for Cardiovascular Disease Prevention |
| Study Chair: | Margareta Grind, MD PhD FFPM | Medicine and Sciences AstraZeneca |
More Information
No publications provided
| Responsible Party: | Michael Cressman - Medical Science Director, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00525824 History of Changes |
| Other Study ID Numbers: | D356FC00003 |
| Study First Received: | September 5, 2007 |
| Results First Received: | September 3, 2009 |
| Last Updated: | May 11, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Hypercholesterolaemia Coronary Heart Disease (CHD) Atherosclerosis |
Additional relevant MeSH terms:
|
Atherosclerosis Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Hypercholesterolemia Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Simvastatin Rosuvastatin Ezetimibe Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013