Official Title: “A 12-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to ABT-335 and Rosuvastatin Monotherapy in Subjects With Type IIa and IIb Dyslipidemia”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Other: ABT-335 and Rosuvastatin Combination
  • 12 Weeks, see Arm for intervention description
• Drug: ABT-335
  • 12 Weeks, see Arm for intervention description
• Drug: rosuvastatin calcium
  • 12 Weeks, see Arm for intervention description

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: ABT-335 and Rosuvastatin Calcium
  • ABT-335 135mg in combination with rosuvastatin calcium 5mg QD
• Placebo Comparator: ABT-335
  • ABT-335 135mg monotherapy QD
• Placebo Comparator: Rosuvastatin Calcium
  • Rosuvastatin calcium 5mg monotherapy QD

Primary Measures

• Triglycerides
  • Time Frame: 12 Weeks
    Safety Issue?: No
• HDL-C
  • Time Frame: 12 Weeks
    Safety Issue?: No
• Direct LDL-C
  • Time Frame: 12 Weeks
    Safety Issue?: No

Secondary Measures

• Non-HDL-C and VLDL
  • Time Frame: 12 Weeks
    Safety Issue?: No
• Total Cholesterol
  • Time Frame: 12 Weeks
    Safety Issue?: No
• Lipoprotein apoB
  • Time Frame: 12 Weeks
    Safety Issue?: No
• High sensitivity C-reactive protein (hsCRP)
  • Time Frame: 12 Weeks
    Safety Issue?: No

Inclusion Criteria:

• Adult male and female subjects who voluntarily sign the informed consent and meet the lipid inclusion criteria for dyslipidemia.
• Subject is >= 18 years of age at the time of the Pre-screening Visit.
• Subjects must agree to utilize adequate birth control methods and to adhere to the 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00463606

Study ID Number: M06-844

ClinicalTrials.gov Identifier: NCT00463606

Health Authority: United States: Food and Drug Administration