A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)

Organon

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Comparator: Placebo (unspecified); Drug: Comparator : rosuvastatin calcium; Drug: ezetimibe (+) simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00479713

2007_552

0653A-809

Details and patient eligibility

About

This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.

Enrollment: 618 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant is currently taking a statin medication for the treatment of high cholesterol
• Participant has an LDL-C level that is greater than or equal to 100 mg/dl and less than or equal to 190 mg/dl

Exclusion criteria

• Women who are pregnant or nursing, or women who intend to become pregnant
• Participant has any condition, situation, or is currently taking any medication that might pose a risk to the participant or interfere with participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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618 participants in 2 patient groups

1

Experimental group

Description:

Arm 1: drug

Treatment:

Drug: Comparator: Placebo (unspecified)

Drug: ezetimibe (+) simvastatin

Drug: Comparator: Placebo (unspecified)

2

Active Comparator group

Description:

Arm 2: active comparator

Treatment:

Drug: Comparator : rosuvastatin calcium

Drug: Comparator: Placebo (unspecified)

Drug: Comparator: Placebo (unspecified)