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

Primary Purpose

Hypercholesterolemia, Coronary Heart Disease, Atherosclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rosuvastatin (Crestor)
Ezetimibe
Simvastatin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hypercholesterolaemia, Coronary Heart Disease (CHD), Atherosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment
Percent change in TC = (Combination treatment value - Baseline value)/Baseline value*100
Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment
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
Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment
Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value*100
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
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
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
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
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
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
Percent Change in LDL-C After 6 Weeks Monotherapy
Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value*100

Full Information

First Posted
September 5, 2007
Last Updated
May 11, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00525824
Brief Title
12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief 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%

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Coronary Heart Disease, Atherosclerosis
Keywords
Hypercholesterolaemia, Coronary Heart Disease (CHD), Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1743 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rosuvastatin (Crestor)
Intervention Description
10mg and 20 mg
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Intervention Description
10 mg
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
40mg and 80 mg
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment
Description
Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Time Frame
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Secondary Outcome Measure Information:
Title
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment
Description
Percent change in HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Time Frame
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Title
Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment
Description
Percent change in TC = (Combination treatment value - Baseline value)/Baseline value*100
Time Frame
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Title
Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment
Description
Percent change in TG = (Combination treatment value - Baseline value)/Baseline value*100
Time Frame
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Title
Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment
Description
Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Time Frame
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Title
Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment
Description
Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value*100
Time Frame
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Title
Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment
Description
Percent change in ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100
Time Frame
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Title
Percent Change in TC/HDL-C After 6 Weeks Combination Treatment
Description
Percent change in TC/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Time Frame
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Title
Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment
Description
Percent change in LDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Time Frame
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Title
Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment
Description
Percent change in non-HDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Time Frame
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Title
Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment
Description
Percent change in ApoB/ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100
Time Frame
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Title
Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment
Description
Percent change in hs-CRP = (Combination treatment value - Baseline value)/Baseline value*100
Time Frame
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Title
Percent Change in LDL-C After 6 Weeks Monotherapy
Description
Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value*100
Time Frame
Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christie M Ballantyne, MD FACP FACC
Organizational Affiliation
Centre for Cardiovascular Disease Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margareta Grind, MD PhD FFPM
Organizational Affiliation
Medicine and Sciences AstraZeneca
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Brentwood
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Sao Paulo
State/Province
SP
Country
Brazil
Facility Name
Research Site
City
Santiago
Country
Chile
Facility Name
Research Site
City
Brentwood
Country
Colombia
Facility Name
Research Site
City
Brentwood
Country
Lithuania
Facility Name
Research Site
City
Zwinderen
Country
Netherlands
Facility Name
Research Site
City
Lima
State/Province
San Isidro Lima
Country
Peru
Facility Name
Research Site
City
Brentwood
Country
Venezuela

12. IPD Sharing Statement

Learn more about this trial

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

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