Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood

Abbott

Status and phase: Completed; Phase 3

Conditions: Mixed Dyslipidemia; Coronary Heart Disease; Dyslipidemia

Treatments: Drug: ABT-335; Drug: Placebo; Drug: Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00300456

M05-749

Details and patient eligibility

About

The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.

Enrollment: 657 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with mixed dyslipidemia
• Subjects agree to utilize adequate birth control methods and to adhere to the American Heart Association (AHA) diet.

Exclusion criteria

• Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.
• Patients who are taking certain medications or unstable dose of specific 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: Triple Blind

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657 participants in 6 patient groups, including a placebo group

A

Active Comparator group

Description:

ABT-335 + 20 mg simvastatin

Treatment:

Drug: ABT-335

Drug: Simvastatin

B

Active Comparator group

Description:

ABT-335 + 40 mg simvastatin

Treatment:

Drug: ABT-335

Drug: Simvastatin

C

Placebo Comparator group

Description:

ABT-335 monotherapy

Treatment:

Drug: Placebo

Drug: ABT-335

D

Placebo Comparator group

Description:

20 mg simvastatin monotherapy

Treatment:

Drug: Placebo

Drug: Simvastatin

E

Placebo Comparator group

Description:

40 mg simvastatin monotherapy

Treatment:

Drug: Placebo

Drug: Simvastatin

F

Placebo Comparator group

Description:

80 mg simvastatin monotherapy

Treatment:

Drug: Placebo

Drug: Simvastatin