Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: ezetimibe/simvastatin 10/40; Drug: atorvastatin 40 mg; Drug: atorvastatin 20 mg

• Registration Number: NCT00782184
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-29
• Study First Submitted QC: 2008-10-29
• Study First Posted: 2008-10-31
• Study Start: 2008-11
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2011-09-22
• Results First Submitted QC: 2011-09-22
• Results First Posted: 2011-10-31
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atorvastatin 40 mg	atorvastatin 20 mg	Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period
ezetimibe/simvastatin 10/40	atorvastatin 20 mg	Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period
ezetimibe/simvastatin 10/40	ezetimibe/simvastatin 10/40	Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period
atorvastatin 40 mg	atorvastatin 40 mg	Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low Density Lipoprotein (LDL)-C	Baseline (Treatment Day 1), Treatment Week 6

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio	Baseline (Treatment Day 1), Treatment Week 6
Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol	Baseline (Treatment Day 1), Treatment Week 6
Percent Change From Baseline in Triglycerides	Baseline (Treatment Day 1), Treatment Week 6
Percent Change From Baseline in Apolipoprotein B	Baseline (Treatment Day 1), Treatment Week 6
Percent Change From Baseline in Apolipoprotein A-1	Baseline (Treatment Day 1), Treatment Week 6
Percent Change From Baseline in Apolipoprotein B/A-1 Ratio	Baseline (Treatment Day 1), Treatment Week 6
Number of Participants Reaching LDL-C Target Goal <77 mg/dL	Treatment Week 6	Target LDL-C level of \< 77 mg/dL (2.00 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.
Number of Participants Reaching LDL-C Target Goal <100 mg/dL	Treatment Week 6	Target LDL-C level of \< 100 mg/dL (2.59 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.
Percent Change From Baseline in Non-HDL Cholesterol	Baseline (Treatment Day 1), Treatment Week 6
Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio	Baseline (Treatment Day 1), Treatment Week 6
Number of Participants Reaching LDL-C Target Goals of <70 mg/dL	Treatment Week 6	Target LDL-C level of \< 70 mg/dL (1.81 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.
Percent Change From Baseline in Total Cholesterol	Baseline (Treatment Day 1), Treatment Week 6
Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio	Baseline (Treatment Day 1), Treatment Week 6
Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)	Baseline (Treatment Day 1), Treatment Week 6