12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe
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
Acronym
GRAVITY
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
May 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2007
Primary Completion Date
Sep 2008Actual
Completion Date
Sep 2008Actual
First Submitted Date
Sep 5, 2007
First Submission Date that Met QC Criteria
Sep 5, 2007
First Posted Date
Sep 6, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 3, 2009
Results First Submitted that Met QC Criteria
Sep 3, 2009
Results First Posted Date
Oct 7, 2009Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 11, 2011
Last Update Posted Date
May 13, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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%
Detailed Description
Not provided
Conditions Module
Conditions
Hypercholesterolemia
Coronary Heart Disease
Atherosclerosis
Keywords
Hypercholesterolaemia
Coronary Heart Disease (CHD)
Atherosclerosis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,743Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Rosuvastatin (Crestor)
Drug
10mg and 20 mg
Ezetimibe
Drug
10 mg
Simvastatin
Drug
40mg and 80 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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)
Secondary Outcomes
Measure
Description
Time Frame
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)
Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment
Other Outcomes
Not provided
Eligibility Module
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Christie M Ballantyne, MD FACP FACC
Centre for Cardiovascular Disease Prevention
Principal Investigator
Margareta Grind, MD PhD FFPM
Medicine and Sciences AstraZeneca
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Research Site
Brentwood
Tennessee
United States
Research Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Patients underwent screening procedures (Week -6; Visit 1), and entered a 6-week dietary lead-in period. Those who fulfilled all eligibility criteria (Week -6; Visit 1) and had qualifying lipid values at Visit 2 were randomly allocated (1:1:1:1) to 1 of 4 treatments for a period of 12 weeks.
Recruitment Details
Eight hundred thirty-three patients (with hypercholesterolaemia and CHD or CHD risk equivalent, atherosclerosis or a 10-year CHD risk of >20%) were randomized into the study, from 111 sites located in the United States (56), Peru (13), Netherlands (12), Colombia (8), Argentina (8), Brazil (6), Chile (4) and Lithuania (4).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
FG001
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Buenos Aires
Argentina
Research Site
São Paulo
São Paulo
Brazil
Research Site
Santiago
Chile
Research Site
Brentwood
Colombia
Research Site
Brentwood
Lithuania
Research Site
Zwinderen
Netherlands
Research Site
Lima
San Isidro Lima
Peru
Research Site
Brentwood
Venezuela
FG002
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
FG003
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
FG000214 subjectsRandomized population
FG001214 subjectsRandomized population
FG002202 subjectsRandomized population
FG003203 subjectsRandomized population
COMPLETED
FG000195 subjects
FG001186 subjects
FG002183 subjects
FG003188 subjects
NOT COMPLETED
FG00019 subjects
FG00128 subjects
FG00219 subjects
FG00315 subjects
Type
Comment
Reasons
Adverse Event
FG0007 subjects
FG00111 subjects
FG0026 subjects
FG0037 subjects
Withdrawal by Subject
FG0005 subjects
FG0019 subjects
FG0023 subjects
FG0034 subjects
Lost to Follow-up
FG0004 subjects
FG0012 subjects
FG0024 subjects
FG0030 subjects
Incorrect enrolment/mis-randomisation
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0032 subjects
Severe non-compliance
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
Safety reasons
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Other
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG0031 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
BG001
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
BG002
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
BG003
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000214
BG001214
BG002202
BG003203
BG004833
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00062.2± 10.14
BG00161.8± 9.93
BG00261.9± 9.37
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00091.0000
BG00197.0000
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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
Posted
Mean
Standard Deviation
Percentage
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
ID
Title
Description
OG000
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
OG001
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
OG002
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
OG003
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
Units
Counts
Participants
OG000210
OG001204
OG002199
OG003
Title
Denominators
Categories
Title
Measurements
OG000-59.7200± 14.1660
OG001-63.4800± 16.6970
OG002-55.2200± 15.7500
OG003
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
Posted
Mean
Standard Deviation
Percentage
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
ID
Title
Description
OG000
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
OG001
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
OG002
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
OG003
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
Units
Counts
Secondary
Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment
Percent change in TC = (Combination treatment value - Baseline value)/Baseline value*100
Posted
Mean
Standard Deviation
Percentage
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
ID
Title
Description
OG000
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
OG001
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
OG002
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
OG003
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
Units
Counts
Secondary
Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment
Percent change in TG = (Combination treatment value - Baseline value)/Baseline value*100
Posted
Mean
Standard Deviation
Percentage
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
ID
Title
Description
OG000
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
OG001
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
OG002
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
OG003
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
Units
Counts
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
Posted
Mean
Standard Deviation
Percentage
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
ID
Title
Description
OG000
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
OG001
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
OG002
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
OG003
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
Units
Counts
Secondary
Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment
Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value*100
Posted
Mean
Standard Deviation
Percentage
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
ID
Title
Description
OG000
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
OG001
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
OG002
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
OG003
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
Units
Counts
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
Posted
Mean
Standard Deviation
Percentage
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
ID
Title
Description
OG000
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
OG001
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
OG002
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
OG003
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
Units
Counts
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
Posted
Mean
Standard Deviation
Percentage
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
ID
Title
Description
OG000
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
OG001
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
OG002
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
OG003
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
Units
Counts
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
Posted
Mean
Standard Deviation
Percentage
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
ID
Title
Description
OG000
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
OG001
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
OG002
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
OG003
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
Units
Counts
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
Posted
Mean
Standard Deviation
Percentage
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
ID
Title
Description
OG000
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
OG001
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
OG002
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
OG003
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
Units
Counts
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
Posted
Mean
Standard Deviation
Percentage
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
ID
Title
Description
OG000
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
OG001
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
OG002
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
OG003
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
Units
Counts
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
Posted
Mean
Full Range
Percentage
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
ID
Title
Description
OG000
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
OG001
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
OG002
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
OG003
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
Units
Counts
Secondary
Percent Change in LDL-C After 6 Weeks Monotherapy
Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value*100
Posted
Mean
Standard Deviation
Percentage
Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward)
ID
Title
Description
OG000
R10 to R10 + E10
Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
OG001
R20 to R20 + E10
Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
OG002
S40 to S40 + E10
Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
OG003
S80 to S80 + E10
Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
Units
Counts
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Rosuvastatin 10 mg
Rosuvastatin 10 mg Monotherapy arm
3
25
EG001
Rosuvastatin 20 mg
Rosuvastatin 20 mg Monotherapy arm
5
31
EG002
Simvastatin 40 mg
Simvastatin 40 mg Monotherapy arm
1
28
EG003
Simvastatin 80 mg
Simvastatin 80 mg Monotherapy arm
3
26
EG004
Rosu 10 mg + Eze 10 mg
Rosuvastatin 10 mg + Ezetimibe 10 mg
4
18
EG005
Rosu 20 mg + Eze 10 mg
Rosuvastatin 20 mg + Ezetimibe 10 mg
1
23
EG006
Simva 40 mg + Eze 10 mg
Simvastatin 40 mg + Ezetimibe 10 mg
7
24
EG007
Simva 80 mg + Eze 10 mg
Simvastatin 80 mg + Ezetimibe 10 mg
4
21
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected213 at risk
EG0010 affected212 at risk
EG0020 affected199 at risk
EG0030 affected203 at risk
EG0040 affected200 at risk
EG0050 affected191 at risk
EG0060 affected189 at risk
EG0071 affected192 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected213 at risk
EG0011 affected212 at risk
EG0020 affected199 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0001 affected213 at risk
EG0010 affected212 at risk
EG0020 affected199 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected213 at risk
EG0010 affected212 at risk
EG0020 affected199 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected213 at risk
EG0011 affected212 at risk
EG0020 affected199 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected213 at risk
EG0010 affected212 at risk
EG0020 affected199 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected213 at risk
EG0011 affected212 at risk
EG0020 affected199 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected213 at risk
EG0010 affected212 at risk
EG0020 affected199 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 affected213 at risk
EG0010 affected212 at risk
EG0020 affected199 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 affected213 at risk
EG0010 affected212 at risk
EG0020 affected199 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0001 affected213 at risk
EG0010 affected212 at risk
EG0020 affected199 at risk
EG003
Staphylococcal abscess
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 affected213 at risk
EG0010 affected212 at risk
EG0020 affected199 at risk
EG003
Fracture displacement
Injury, poisoning and procedural complications
MedDRA 11.1
Systematic Assessment
EG0000 affected213 at risk
EG0010 affected212 at risk
EG0020 affected199 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected213 at risk
EG0010 affected212 at risk
EG0020 affected199 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected213 at risk
EG0010 affected212 at risk
EG0020 affected199 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.1
Systematic Assessment
EG0000 affected213 at risk
EG0010 affected212 at risk
EG0020 affected199 at risk
EG003
Non-Hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.1
Systematic Assessment
EG0000 affected213 at risk
EG0010 affected212 at risk
EG0020 affected199 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)