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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782184
• Other study ID #: 0653A-134
• Secondary ID: 2008_576
• Status: Completed
• Phase: Phase 3
• Start date: November 2008
• Est. completion date: September 2010

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• ezetimibe/simvastatin 10/40
ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks.
• atorvastatin 40 mg
atorvastatin 40 mg tablet once daily for 6 weeks
• atorvastatin 20 mg
All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Low Density Lipoprotein (LDL)-C		Baseline (Treatment Day 1), Treatment Week 6
Secondary	Number of Participants Reaching LDL-C Target Goals of <70 mg/dL	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.	Treatment Week 6
Secondary	Number of Participants Reaching LDL-C Target Goal <77 mg/dL	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.	Treatment Week 6
Secondary	Number of Participants Reaching LDL-C Target Goal <100 mg/dL	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.	Treatment Week 6
Secondary	Percent Change From Baseline in Total Cholesterol		Baseline (Treatment Day 1), Treatment Week 6
Secondary	Percent Change From Baseline in Triglycerides		Baseline (Treatment Day 1), Treatment Week 6
Secondary	Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol		Baseline (Treatment Day 1), Treatment Week 6
Secondary	Percent Change From Baseline in Non-HDL Cholesterol		Baseline (Treatment Day 1), Treatment Week 6
Secondary	Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio		Baseline (Treatment Day 1), Treatment Week 6
Secondary	Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio		Baseline (Treatment Day 1), Treatment Week 6
Secondary	Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio		Baseline (Treatment Day 1), Treatment Week 6
Secondary	Percent Change From Baseline in Apolipoprotein B		Baseline (Treatment Day 1), Treatment Week 6
Secondary	Percent Change From Baseline in Apolipoprotein A-1		Baseline (Treatment Day 1), Treatment Week 6
Secondary	Percent Change From Baseline in Apolipoprotein B/A-1 Ratio		Baseline (Treatment Day 1), Treatment Week 6
Secondary	Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)		Baseline (Treatment Day 1), Treatment Week 6