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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
760
ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set)
The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time frame: Baseline to 12 Weeks
Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set)
The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time frame: Baseline to 12 Weeks
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)
The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.
Time frame: Baseline to 12 Weeks
Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set)
The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.
Time frame: Baseline to 12 Weeks
Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set)
The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
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Site Reference ID/Investigator# 5469
Birmingham, Alabama, United States
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...and 158 more locations
Time frame: Baseline to 12 Weeks
Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set)
The mean percent change from baseline to the final visit in very-low-density lipoprotein cholesterol (VLDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time frame: Baseline to 12 Weeks
Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set)
The mean percent change from baseline to the final visit in apolipoprotein B (ApoB), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time frame: Baseline to 12 Weeks
Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set)
The median percent change from baseline to the final visit in high sensitivity C-reactive protein (hsCRP), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time frame: Baseline to 12 Weeks
Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set)
The mean percent change from baseline to the final visit in total cholesterol, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
Time frame: Baseline to 12 Weeks