The primary efficacy endpoint was percent change in LDL-C from baseline to Week 26. At Week 26, the mean and median percent changes in LDL-C from baseline were -40% (paired t-test p<0.001) and -50%, respectively, based on the intent-to-treat population with last observation carried forward (LOCF) for patients who discontinued prematurely. The mean percent change in LDL-C from baseline through Week 26 is shown in Figure 1 for the 23 patients who completed the efficacy period.

Figure 1: Mean Percent Change in LDL-C from Baseline (Week 26 Completers)

Error bars represent 95% confidence intervals of the mean.

Changes in lipids and lipoproteins through the efficacy endpoint at Week 26 are presented in Table 7.

Table 7: Absolute Values and Percent Changes from Baseline in Lipids and Lipoproteins  a Median values with interquartile range and median % change presented for TG.
* Statistically significant compared with baseline based on the pre-specified gatekeeping method for controlling Type I error among the primary and key secondary endpoints.
PARAMETER BASELINE WEEK 26/LOCF (N=29)
Mean (SD) Mean (SD) Mean % Change
LDL-C, direct (mg/dL)  336 (114) 190 (104) -40 *
TC (mg/dL)  430 (135) 258 (118) -36 *
apo B (mg/dL) 259 (80) 148 (74) -39 *
Non-HDL-C (mg/dL) 386 (132) 217 (113) -40
VLDL-C (mg/dL) 21 (10) 13 (9) -29
TG (mg/dL)a 92 [72, 128] 57 [36, 78] -45 *
HDL-C (mg/dL) 44 (11) 41 (13) -7
After Week 26, during the safety phase of the study, adjustments to concomitant lipid-lowering treatments were allowed. For the study population overall, average reductions in LDL-C, TC, apo B, and non-HDL-C were sustained during chronic therapy.

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16 HOW SUPPLIED / STORAGE AND HANDLING

5 mg capsules:
Orange/orange hard gelatin capsule printed with black ink “A733” and “5 mg”
Bottles of 28                                                         NDC 76431-105-01

10 mg capsules:
Orange/white hard gelatin capsule printed with black ink “A733” and “10 mg”
Bottles of 28                                                         NDC 76431-110-01

20 mg capsules:
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Bottles of 28                                                        NDC 76431-120-01

30 mg capsules:
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