Back to resultsMK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ezetimibe 10 mg
atorvastatin
Comparator: rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Patient is at high cardiovascular risk and meets one of the following conditions: has never taken lipid-lowering therapy or has been off such therapy for at least 6 weeks; or, is currently taking a stable dose of certain lipid-lowering agents
- Patient is willing to maintain a cholesterol lowering diet during the study
- Female patients receiving non-cyclical hormone therapy have maintained a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen during the study
Exclusion Criteria:
- Patient is Asian
- Patient routinely has more than 2 alcoholic drinks per day
- Female patient is pregnant or breastfeeding
- Patient has congestive heart failure
- Patient has had a myocardial infarction, coronary bypass surgery, angioplasty, or acute coronary syndrome within 3 months of screening
- Patient has uncontrolled cardiac arrhythmias
- Patient has had a partial ileal or gastric bypass or other significant intestinal malabsorption
- Patient has uncontrolled high blood pressure
- Patient has kidney disease
- Patient has any disease known to influence blood lipid levels
- Patient has any disorders of the blood, digestive system, or nervous system including stroke and degenerative disease that would limit study participation
- Patient has poorly controlled or newly diagnosed diabetes
- Patient is known to be HIV positive
- Patient has a history of cancer in the last 5 years, except certain skin and cervical cancers
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Active Comparator
Active Comparator
Experimental
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Phase I: ezetimibe (EZ) 10 mg + atorvastatin (Atorva) 10 mg
Phase I: Atorvastatin 20 mg
Phase I: Rosuvastatin 10 mg
Phase II: EZ 10mg+Atorva 10mg
Phase II: EZ 10mg + Atorva 20mg [A]
Phase II: Atorva 40mg
Phase II: EZ 10mg + Atorva 20mg [R]
Phase II: Rosuvastatin 20mg
Arm Description
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
Atorvastatin 20 mg tablet once daily for 6 weeks
Rosuvastatin 10 mg tablet once daily for 6 weeks
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase
Outcomes
Primary Outcome Measures
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I)
LDL-C levels measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG≥350 mg/dL (3.95 mmol/L).
Secondary Outcome Measures
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II).
LDL-C levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12). Baseline was defined as the average of the values at Visits 5 and 6. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG ≥350 mg/dL (3.95 mmol/L).
Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I)
Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II)
Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I)
Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II)
Percent Change From Baseline in Total Cholesterol (TC) (Phase I)
TC measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Percent Change From Baseline in Total Cholesterol (TC) (Phase II)
TC levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Percent Change From Baseline in Triglycerides (TG) (Phase I)
TG measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Percent Change From Baseline in Triglycerides (TG) (Phase II)
TG levels measured at Baseline (Week 6: end of Phase I) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I)
HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Percent Change From Baseline in HDL-C (Phase II)
HDL-C levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I)
Apo-B measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Percent Change From Baseline in Apo B (Phase II)
Apo-B levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I)
Apo-A-I measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Percent Change From Baseline in Apo A-I (Phase II)
Apo-A-I levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Percent Change From Baseline in Non-HDL-C (Phase I)
Non-HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Percent Change From Baseline in Non-HDL-C (Phase II)
Non-HDL-C levels calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Percent Change From Baseline in TC/HDL-C Ratio (Phase I)
TC/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Percent Change From Baseline in TC/HDL-C Ratio (Phase II)
TC/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase I)
LDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase II)
LDL-C/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase I)
Apo B/Apo A-I ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase II)
Apo B/Apo A-I Ratio calculated at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase I)
Non HDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase II)
Non HDL-C/HDL-C Ratio calculated at baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) (Phase I)
hs-CRP measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Percent Change From Baseline in Hs-CRP (Phase II)
hs-CRP measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01154036
Brief Title
MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)
Official Title
A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk Who Are Not Adequately Controlled With Atorvastatin 10 mg: A Comparison of the Efficacy and Safety of Switching to Coadministration Ezetimibe and Atorvastatin Versus Doubling the Dose of Atorvastatin or Switching to Rosuvastatin
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not achieved specified low-density lipoprotein cholesterol (LDL-C) levels. The primary hypothesis is that the co-administration of ezetimibe 10 mg and atorvastatin 10 mg will be superior to both atorvastatin 20 mg and rosuvastatin 10 mg with respect to the percentage reduction in low-density lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.
Detailed Description
This is a 18 week randomized, double-blind, active-controlled, multicenter study composed of a 6 week screening/run-in and 12 week double-blind treatment period (composed of 2 phases; each 6 weeks in duration). Only those participants who do not meet low density lipoprotein-cholesterol (LDL-C) goals at the end of Phase I (Week 6), were eligible to continue into Phase II (Week 12).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1547 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase I: ezetimibe (EZ) 10 mg + atorvastatin (Atorva) 10 mg
Arm Type
Experimental
Arm Description
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
Arm Title
Phase I: Atorvastatin 20 mg
Arm Type
Active Comparator
Arm Description
Atorvastatin 20 mg tablet once daily for 6 weeks
Arm Title
Phase I: Rosuvastatin 10 mg
Arm Type
Active Comparator
Arm Description
Rosuvastatin 10 mg tablet once daily for 6 weeks
Arm Title
Phase II: EZ 10mg+Atorva 10mg
Arm Type
Experimental
Arm Description
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I
Arm Title
Phase II: EZ 10mg + Atorva 20mg [A]
Arm Type
Experimental
Arm Description
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
Arm Title
Phase II: Atorva 40mg
Arm Type
Active Comparator
Arm Description
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
Arm Title
Phase II: EZ 10mg + Atorva 20mg [R]
Arm Type
Experimental
Arm Description
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
Arm Title
Phase II: Rosuvastatin 20mg
Arm Type
Active Comparator
Arm Description
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase
Intervention Type
Drug
Intervention Name(s)
ezetimibe 10 mg
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Type
Drug
Intervention Name(s)
Comparator: rosuvastatin
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I)
Description
LDL-C levels measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG≥350 mg/dL (3.95 mmol/L).
Time Frame
Baseline and Week 6 (end of Phase I )
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II).
Description
LDL-C levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12). Baseline was defined as the average of the values at Visits 5 and 6. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG ≥350 mg/dL (3.95 mmol/L).
Time Frame
Baseline (Week 6) and Week 12
Title
Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I)
Time Frame
Week 6 (End of Phase I)
Title
Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II)
Time Frame
Week 12 (End of Phase II)
Title
Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I)
Time Frame
Week 6 (End of Phase I)
Title
Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II)
Time Frame
Week 12 (end of Phase II)
Title
Percent Change From Baseline in Total Cholesterol (TC) (Phase I)
Description
TC measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Time Frame
Baseline and Week 6 (end of Phase I)
Title
Percent Change From Baseline in Total Cholesterol (TC) (Phase II)
Description
TC levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Time Frame
Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Title
Percent Change From Baseline in Triglycerides (TG) (Phase I)
Description
TG measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Time Frame
Baseline and Week 6 (end of Phase I)
Title
Percent Change From Baseline in Triglycerides (TG) (Phase II)
Description
TG levels measured at Baseline (Week 6: end of Phase I) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Time Frame
Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Title
Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I)
Description
HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Time Frame
Baseline and Week 6 (end of Phase I)
Title
Percent Change From Baseline in HDL-C (Phase II)
Description
HDL-C levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Time Frame
Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Title
Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I)
Description
Apo-B measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Time Frame
Baseline and Week 6 (end of Phase I)
Title
Percent Change From Baseline in Apo B (Phase II)
Description
Apo-B levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Time Frame
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Title
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I)
Description
Apo-A-I measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Time Frame
Baseline and Week 6 (end of Phase I)
Title
Percent Change From Baseline in Apo A-I (Phase II)
Description
Apo-A-I levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Time Frame
Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Title
Percent Change From Baseline in Non-HDL-C (Phase I)
Description
Non-HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Time Frame
Baseline and Week 6 (end of Phase I)
Title
Percent Change From Baseline in Non-HDL-C (Phase II)
Description
Non-HDL-C levels calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Time Frame
Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Title
Percent Change From Baseline in TC/HDL-C Ratio (Phase I)
Description
TC/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Time Frame
Baseline and Week 6 (end of Phase I)
Title
Percent Change From Baseline in TC/HDL-C Ratio (Phase II)
Description
TC/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Time Frame
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Title
Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase I)
Description
LDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Time Frame
Baseline and Week 6 (end of Phase I)
Title
Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase II)
Description
LDL-C/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Time Frame
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Title
Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase I)
Description
Apo B/Apo A-I ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Time Frame
Baseline and Week 6 (end of Phase I)
Title
Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase II)
Description
Apo B/Apo A-I Ratio calculated at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Time Frame
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Title
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase I)
Description
Non HDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Time Frame
Baseline and Week 6 (end of Phase I)
Title
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase II)
Description
Non HDL-C/HDL-C Ratio calculated at baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Time Frame
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Title
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) (Phase I)
Description
hs-CRP measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Time Frame
Baseline and Week 6 (end of Phase I)
Title
Percent Change From Baseline in Hs-CRP (Phase II)
Description
hs-CRP measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Time Frame
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is at high cardiovascular risk and meets one of the following conditions: has never taken lipid-lowering therapy or has been off such therapy for at least 6 weeks; or, is currently taking a stable dose of certain lipid-lowering agents
Patient is willing to maintain a cholesterol lowering diet during the study
Female patients receiving non-cyclical hormone therapy have maintained a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen during the study
Exclusion Criteria:
Patient is Asian
Patient routinely has more than 2 alcoholic drinks per day
Female patient is pregnant or breastfeeding
Patient has congestive heart failure
Patient has had a myocardial infarction, coronary bypass surgery, angioplasty, or acute coronary syndrome within 3 months of screening
Patient has uncontrolled cardiac arrhythmias
Patient has had a partial ileal or gastric bypass or other significant intestinal malabsorption
Patient has uncontrolled high blood pressure
Patient has kidney disease
Patient has any disease known to influence blood lipid levels
Patient has any disorders of the blood, digestive system, or nervous system including stroke and degenerative disease that would limit study participation
Patient has poorly controlled or newly diagnosed diabetes
Patient is known to be HIV positive
Patient has a history of cancer in the last 5 years, except certain skin and cervical cancers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
25985907
Citation
Krempf M, Simpson RJ Jr, Ramey DR, Brudi P, Giezek H, Tomassini JE, Lee R, Farnier M. Patient and physician factors influence decision-making in hypercholesterolemia: a questionnaire-based survey. Lipids Health Dis. 2015 May 19;14:45. doi: 10.1186/s12944-015-0037-y.
Results Reference
derived
PubMed Identifier
24063830
Citation
Bays HE, Averna M, Majul C, Muller-Wieland D, De Pellegrin A, Giezek H, Lee R, Lowe RS, Brudi P, Triscari J, Farnier M. Efficacy and safety of ezetimibe added to atorvastatin versus atorvastatin uptitration or switching to rosuvastatin in patients with primary hypercholesterolemia. Am J Cardiol. 2013 Dec 15;112(12):1885-95. doi: 10.1016/j.amjcard.2013.08.031. Epub 2013 Sep 21.
Results Reference
derived
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MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)
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