Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium 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: Rosuvastatin Calcium; Drug: Placebo; Drug: ABT-335

Study type: Interventional

Funder types: Industry

Identifiers

NCT00300482

M05-748

Details and patient eligibility

About

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

Enrollment: 1,445 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with mixed dyslipidemia

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: Quadruple Blind

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1,445 participants in 6 patient groups, including a placebo group

A

Active Comparator group

Description:

ABT-335 + 10 mg rosuvastatin

Treatment:

Drug: Rosuvastatin Calcium

Drug: ABT-335

B

Active Comparator group

Description:

ABT-335 + 20 mg rosuvastatin

Treatment:

Drug: Rosuvastatin Calcium

Drug: ABT-335

C

Placebo Comparator group

Description:

ABT-335 monotherapy

Treatment:

Drug: Placebo

Drug: ABT-335

D

Placebo Comparator group

Description:

10 mg rosuvastatin monotherapy

Treatment:

Drug: Placebo

Drug: Rosuvastatin Calcium

E

Placebo Comparator group

Description:

20 mg rosuvastatin monotherapy

Treatment:

Drug: Placebo

Drug: Rosuvastatin Calcium

F

Placebo Comparator group

Description:

40 mg rosuvastatin monotherapy

Treatment:

Drug: Placebo

Drug: Rosuvastatin Calcium