Trial record 3 of 3 for:    mk-0653c

MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01154036
First received: June 29, 2010
Last updated: December 23, 2013
Last verified: December 2013

June 29, 2010
December 23, 2013
July 2010
September 2012   (final data collection date for primary outcome measure)
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I) [ Time Frame: Baseline and Week 6 (end of Phase I ) ] [ Designated as safety issue: No ]
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).
  • Percent change in low-density lipoprotein cholesterol (LDL-C) with ezetimibe 10 mg + atorvastatin 10 mg versus atorvastatin 20 mg [ Time Frame: Baseline (Phase I) and Week 6 (End of 6 Week Phase I Treatment Period) ] [ Designated as safety issue: No ]
  • Percent change in low-density lipoprotein cholesterol (LDL-C) with ezetimibe 10 mg + atorvastatin 10 mg versus rosuvastatin 10 mg [ Time Frame: Baseline (Phase I) and Week 6 (End of 6 Week Phase I Treatment Period) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01154036 on ClinicalTrials.gov Archive Site
  • Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II). [ Time Frame: Baseline (Week 6) and Week 12 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 6 (End of Phase I) ] [ Designated as safety issue: No ]
  • Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II) [ Time Frame: Week 12 (End of Phase II) ] [ Designated as safety issue: No ]
  • Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I) [ Time Frame: Week 6 (End of Phase I) ] [ Designated as safety issue: No ]
  • Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II) [ Time Frame: Week 12 (end of Phase II) ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Total Cholesterol (TC) (Phase I) [ Time Frame: Baseline and Week 6 (end of Phase I) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Week 6 (end of Phase I) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Week 6 (end of Phase I) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Week 6 (end of Phase I) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Week 6 (end of Phase I) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Week 6 (end of Phase I) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Week 6 (end of Phase I) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Week 6 (end of Phase I) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Week 6 (end of Phase I) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Week 6 (end of Phase I) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Week 6 (end of Phase I) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II) ] [ Designated as safety issue: No ]
    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.
  • Percent change in low-density lipoprotein cholesterol (LDL-C) with ezetimibe 10 mg + atorvastatin 20 mg versus atorvastatin 40 mg [ Time Frame: Week 6 (Baseline for Phase II) and Week 12 (End of 6 Week Phase II Treatment Period) ] [ Designated as safety issue: No ]
  • Percent change in low-density lipoprotein cholesterol (LDL-C) with ezetimibe 10 mg + atorvastatin 20 mg versus rosuvastatin 20 mg [ Time Frame: Week 6 (Baseline for Phase II) and Week 12 (End of 6 Week Phase II Treatment Period) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)
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

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: ezetimibe 10 mg
  • Drug: atorvastatin
  • Drug: Comparator: rosuvastatin
  • Experimental: Phase I: ezetimibe (EZ) 10 mg + atorvastatin (Atorva) 10 mg
    Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
    Interventions:
    • Drug: ezetimibe 10 mg
    • Drug: atorvastatin
  • Active Comparator: Phase I: Atorvastatin 20 mg
    Atorvastatin 20 mg tablet once daily for 6 weeks
    Intervention: Drug: atorvastatin
  • Active Comparator: Phase I: Rosuvastatin 10 mg
    Rosuvastatin 10 mg tablet once daily for 6 weeks
    Intervention: Drug: Comparator: rosuvastatin
  • Experimental: Phase II: EZ 10mg+Atorva 10mg
    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
    Interventions:
    • Drug: ezetimibe 10 mg
    • Drug: atorvastatin
  • Experimental: Phase II: EZ 10mg + Atorva 20mg [A]
    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
    Interventions:
    • Drug: ezetimibe 10 mg
    • Drug: atorvastatin
  • Active Comparator: Phase II: Atorva 40mg
    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
    Intervention: Drug: atorvastatin
  • Experimental: Phase II: EZ 10mg + Atorva 20mg [R]
    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
    Interventions:
    • Drug: ezetimibe 10 mg
    • Drug: atorvastatin
  • Active Comparator: Phase II: Rosuvastatin 20mg
    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: Drug: Comparator: rosuvastatin
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. PubMed PMID: 24063830.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1547
October 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01154036
0653C-162, 2010_517
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP