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

Atherosclerosis Clinical Trial

— GRAVITY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525824
• Other study ID #: D356FC00003
• Status: Completed
• Phase: Phase 3
• First received: September 5, 2007
• Last updated: May 11, 2011
• Start date: August 2007
• Est. completion date: September 2008

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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%

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1743
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Hypercholesterolemia
• Myocardial Ischemia

Intervention

Drug:
• Rosuvastatin (Crestor)
10mg and 20 mg
• Ezetimibe
10 mg
• Simvastatin
40mg and 80 mg

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Brazil	Research Site	Sao Paulo	SP
Chile	Research Site	Santiago
Colombia	Research Site	Brentwood
Lithuania	Research Site	Brentwood
Netherlands	Research Site	Zwinderen
Peru	Research Site	Lima	San Isidro Lima
United States	Research Site	Brentwood	Tennessee
Venezuela	Research Site	Brentwood

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment	Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value*100	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	No
Secondary	Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment	Percent change in HDL-C = (Combination treatment value - Baseline value)/Baseline value*100	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	No
Secondary	Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment	Percent change in TC = (Combination treatment value - Baseline value)/Baseline value*100	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	No
Secondary	Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment	Percent change in TG = (Combination treatment value - Baseline value)/Baseline value*100	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	No
Secondary	Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment	Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value*100	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	No
Secondary	Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment	Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value*100	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	No
Secondary	Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment	Percent change in ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	No
Secondary	Percent Change in TC/HDL-C After 6 Weeks Combination Treatment	Percent change in TC/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	No
Secondary	Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment	Percent change in LDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	No
Secondary	Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment	Percent change in non-HDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	No
Secondary	Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment	Percent change in ApoB/ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	No
Secondary	Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment	Percent change in hs-CRP = (Combination treatment value - Baseline value)/Baseline value*100	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	No
Secondary	Percent Change in LDL-C After 6 Weeks Monotherapy	Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value*100	Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward)	No