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

Organon

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: ezetimibe/simvastatin 10/40; Drug: atorvastatin 40 mg; Drug: atorvastatin 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00782184

0653A-134

2008_576

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups

ezetimibe/simvastatin 10/40

Experimental group

Description:

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

Treatment:

Drug: atorvastatin 20 mg

Drug: ezetimibe/simvastatin 10/40

atorvastatin 40 mg

Active Comparator group

Description:

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

Treatment:

Drug: atorvastatin 20 mg

Drug: atorvastatin 40 mg