Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood

Abbott

Status and phase: Completed; Phase 3

Conditions: Mixed Dyslipidemia; Coronary Heart Disease; Dyslipidemias; Combined (Atherogenic) Dyslipidemia

Treatments: Drug: ABT-335; Drug: ezetimibe; Drug: atorvastatin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00639158

M10-275

Details and patient eligibility

About

The primary purpose of this study is to compare the safety and efficacy of ABT-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.

Enrollment: 543 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with mixed dyslipidemia (trigylcerides, > or = to 150 mg/dL to < 400 mg/dL; HDL-C < 40 mg/dL for males, < 50 mg/dL for females; LDL-C, > or = to 130 mg/dL).
• Subjects must agree to use adequate birth control methods and to adhere to the American Heart Association (AHA) Diet.

Exclusion criteria

• Subjects with unstable or uncontrolled medical conditions considered inappropriate in a clinical trial.
• Subjects with an unstable dose of medications or receiving Coumadin, oral, intravenous or intramuscular cyclosporine, statins, or certain other medications.
• Women who are pregnant or plan on becoming pregnant, or women who are lactating.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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543 participants in 2 patient groups, including a placebo group

ABT-335 + atorvastatin + ezetimibe

Active Comparator group

Treatment:

Drug: atorvastatin

Drug: ezetimibe

Drug: ABT-335

Placebo + atorvastatin + ezetimibe

Placebo Comparator group

Treatment:

Drug: atorvastatin

Drug: ezetimibe

Drug: placebo