Conditions: Hypercholesterolemia Dyslipidemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 760
Healthy volunteers: no

Brief summary:
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.

Detailed description:
There are 3 treatment groups in the study: ABT-335 135 mg in combination with rosuvastatin 5 mg, ABT-335 135 mg monotherapy, and rosuvastatin 5 mg monotherapy. The 3 primary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in HDL-C and TG comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy, and mean percent change in LDL-C comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to ABT-335 135 mg monotherapy. The 6 secondary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in Non-HDL-C comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to ABT-335 135 mg monotherapy, mean percent change in Non-HDL-C, VLDL-C, ApoB, and Total Cholesterol comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy, and median percent change in hsCRP comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy).

Arms:
arm 1: ABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks arm 2: ABT-335 135mg monotherapy administered orally, once daily for 12 weeks arm 3: Rosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks

Interventions: intervention 1: ABT-335 and rosuvastatin calcium intervention 2: ABT-335 intervention 3: rosuvastatin calcium
Intervention descriptions: intervention 1: ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks intervention 2: ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks intervention 3: Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks

Protocol document: