Study Comparing the Safety and Efficacy of ABT-335 and Simvastatin Combination Therapy to Monotherapy in Subjects With Mixed Dyslipidemia

Condition(s) targeted: Dyslipidemias

Intervention: ABT-335 (Drug); simvastatin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Susan Buttler, Study Director, Affiliation: Abbott

The purpose of this study is to evaluate the safety and efficacy of ABT-335 and simvastatin combination therapy to monotherapy in subjects with mixed dyslipidemia.

Official title: A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 and Simvastatin Combination Therapy to ABT-335 and Simvastatin Monotherapy in Subjects With Mixed Dyslipidemia

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Triglycerides

High density lipoprotein-cholesterol (HDL-C)

Direct low density lipoprotein-cholesterol (LDL-C)

Secondary outcome:

Non-HDL-C

Very low density lipoprotein-cholesterol (VLDL-C)

Total cholesterol

Lipoprotein apoB

High sensitivity C-reactive protein (hsCRP)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult male and female subjects who voluntarily sign the informed consent and meet the

lipid inclusion criteria for mixed dyslipidemia

- In addition, they must agree to utilize adequate birth control methods and to adhere

to the American Heart Association (AHA) diet.

Exclusion Criteria:

- Subjects with unstable medical conditions, medical conditions considered inappropriate

in a clinical trial or subjects who are taking excluded concomitant medications are not allowed in the study.

Global Medical Information, North Chicago, Illinois 60064, United States

Starting date: March 2006
Last updated: February 2, 2007