Clinical trial NCT00782184: Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)
Official title: A Randomized, Double-Blind, Active-Controlled Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With Atorvastatin: A Comparison of Switching to a Combination Tablet Ezetimibe/Simvastatin Versus Doubling the Baseline Dose of Atorvastatin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.


Eligibility criteria: Inclusion Criteria:

* Participants who are either statin naive or on approved lipid lowering therapy for 6 weeks prior to study initiation
* Participant meets Adult Treatment Panel (ATP) III High Risk criteria

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Participant consumes more than 14 alcoholic beverages per week
* Participant has been treated with an investigational drug within the last 30 days
* Participant has congestive heart failure (New York Heart Association \[NYHA\] Type III or IV)
* Participant has had gastric bypass
* Participant is newly diagnosed with type 1 or 2 diabetes
* Participant is Human Immunodeficiency Virus (HIV) positive
* Participant has a history of drug or alcohol abuse within the last 5 years

Primary outcomes:
measure: Percent Change From Baseline in Low Density Lipoprotein (LDL)-C
timeFrame: Baseline (Treatment Day 1), Treatment Week 6
Secondary outcomes:
measure: Number of Participants Reaching LDL-C Target Goals of <70 mg/dL
timeFrame: Treatment Week 6
measure: Number of Participants Reaching LDL-C Target Goal <77 mg/dL
timeFrame: Treatment Week 6
measure: Number of Participants Reaching LDL-C Target Goal <100 mg/dL
timeFrame: Treatment Week 6
measure: Percent Change From Baseline in Total Cholesterol
timeFrame: Baseline (Treatment Day 1), Treatment Week 6
measure: Percent Change From Baseline in Triglycerides
timeFrame: Baseline (Treatment Day 1), Treatment Week 6
measure: Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol
timeFrame: Baseline (Treatment Day 1), Treatment Week 6
measure: Percent Change From Baseline in Non-HDL Cholesterol
timeFrame: Baseline (Treatment Day 1), Treatment Week 6
measure: Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio
timeFrame: Baseline (Treatment Day 1), Treatment Week 6
measure: Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio
timeFrame: Baseline (Treatment Day 1), Treatment Week 6
measure: Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio
timeFrame: Baseline (Treatment Day 1), Treatment Week 6
measure: Percent Change From Baseline in Apolipoprotein B
timeFrame: Baseline (Treatment Day 1), Treatment Week 6
measure: Percent Change From Baseline in Apolipoprotein A-1
timeFrame: Baseline (Treatment Day 1), Treatment Week 6
measure: Percent Change From Baseline in Apolipoprotein B/A-1 Ratio
timeFrame: Baseline (Treatment Day 1), Treatment Week 6
measure: Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
timeFrame: Baseline (Treatment Day 1), Treatment Week 6
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Hing Ling PK, Civeira F, Dan AG, Hanson ME, Massaad R, De Tilleghem Cle B, Milardo C, Triscari J. Ezetimibe/simvastatin 10/40 mg versus atorvastatin 40 mg in high cardiovascular risk patients with primary hypercholesterolemia: a randomized, double-blind, active-controlled, multicenter study. Lipids Health Dis. 2012 Jan 31;11:18. doi: 10.1186/1476-511X-11-18.