To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)

Organon

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Comparator: Placebo to niacin (ER); Drug: Comparator: ezetimibe (+) simvastatin; Drug: Comparator: niacin (ER) tablet; Drug: Comparator: ezetimibe and simvastatin; Drug: Comparator: ezetimibe/simvastatin and niacin (ER); Drug: Comparator: ezetimibe/simvastatin + niacin (ER); Drug: Comparator: Placebo to ezetimibe/simvastatin; Drug: Comparator: Placebo to Niacin (ER)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00271817

0653A-091

2005_091

Details and patient eligibility

About

To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.

Enrollment: 1,220 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL
• Patient willing to be on a low-cholesterol diet

Exclusion criteria

• Pregnant or lactating women or intending to become pregnant
• Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet
• Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin
• Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,220 participants in 5 patient groups, including a placebo group

Part 1 - Arm 1

Active Comparator group

Description:

ezetimibe/simvastatin combination tablet + niacin (ER)

Treatment:

Drug: Comparator: ezetimibe/simvastatin + niacin (ER)

Part 1 -Arm 2

Active Comparator group

Description:

ezetimibe/simvastatin

Treatment:

Drug: Comparator: Placebo to Niacin (ER)

Drug: Comparator: ezetimibe (+) simvastatin

Part 1 - Arm 3

Active Comparator group

Description:

Niacin (ER)

Treatment:

Drug: Comparator: niacin (ER) tablet

Drug: Comparator: Placebo to ezetimibe/simvastatin

Part 2 - Arm 1

Active Comparator group

Description:

ezetimibe/simvastatin combination tablet + niacin (ER)

Treatment:

Drug: Comparator: ezetimibe/simvastatin and niacin (ER)

Part 2 - Arm 2

Placebo Comparator group

Description:

ezetimibe/simvastatin combination tablet + niacin (Pbo)

Treatment:

Drug: Comparator: ezetimibe and simvastatin

Drug: Comparator: Placebo to niacin (ER)