| Primary | Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase | Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value * 100 | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | Posted | | Mean | Standard Deviation | percentage | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Rosuva 5 | | | OG001 | Rosuva 10 | | | OG002 | Rosuva 20 | | | OG003 | Placebo | |
| | Units | Counts |
|---|
| Participants | - OG00042
- OG00144
- OG00244
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-38.5± 11.38
- OG001-44.4± 12.15
- OG002-50.2± 13.3
- OG003
|
|
| |
| Secondary | Percent Change in LDL-C and Other Lipid Parameters From Baseline to Week 6, and at End of Double-blind Dose Treatment Phase (Week 12) | Percent change from baseline in LDL-C after six week of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | Posted | | Mean | Standard Deviation | percentage | | 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Rosuva 5 | | | OG001 | Rosuva 10 | | | OG002 | Rosuva 20 | | | OG003 | Placebo | |
| |
| Secondary | Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment | Percent of patients achieving LDL-C < 110 mg/dL out of the total patients in each treatment group | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | Posted | | Number | | Percent of Participants | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Rosuva 5 | | | OG001 | Rosuva 10 | | | OG002 | Rosuva 20 | | | OG003 | Placebo | |
| |
| Secondary | Percent Change in HDL-C | Percent change in high-density lipoprotein cholesterol (HDL-C) after 12 weeks of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | Posted | | Mean | Standard Deviation | percent change | | After 12 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Rosuva 5 | | | OG001 | Rosuva 10 | | | OG002 | Rosuva 20 | | | OG003 | Placebo | |
| |
| Secondary | Percent Change in Non-HDL-C at 12 Weeks | Percent change in non-HDL-C at 12 weeks | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | Posted | | Mean | Standard Deviation | percent change | | After 12 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Rosuva 5 | | | OG001 | Rosuva 10 | | | OG002 | Rosuva 20 | | | OG003 | Placebo | |
| |
| Secondary | Percent Change in Triglycerides (TG) | Percent change in tryglycerides (TG) after 12 weeks of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | Posted | | Mean | Standard Deviation | percent change | | After 12 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Rosuva 5 | | | OG001 | Rosuva 10 | | | OG002 | Rosuva 20 | | | OG003 | Placebo | |
| |
| Secondary | Percent Change in Total Cholesterol (TC) | Percent change from baseline in total cholesteral after 12 weeks of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | Posted | | Mean | Standard Deviation | percent change | | After 12 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Rosuva 5 | | | OG001 | Rosuva 10 | | | OG002 | Rosuva 20 | | | OG003 | Placebo | |
| |
| Secondary | Percent Change in Apolipoprotein A-1 (ApoA-1) | Percent change in ApoA-1 after 12 weeks of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | Posted | | Mean | Standard Deviation | mean percent change | | After 12 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Rosuva 5 | | | OG001 | Rosuva 10 | | | OG002 | Rosuva 20 | | | OG003 | Placebo | |
| |
| Secondary | Percent Change in Apolipoprotein B (ApoB) | Percent change in ApoB after 12 weeks of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | Posted | | Mean | Standard Deviation | mean percent change | | After 12 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Rosuva 5 | | | OG001 | Rosuva 10 | | | OG002 | Rosuva 20 | | | OG003 | Placebo | |
| |
| Secondary | Percent Change in ApoB/ApoA-1 | Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | Posted | | Mean | Standard Deviation | mean percent change | | After 12 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Rosuva 5 | | | OG001 | Rosuva 10 | | | OG002 | Rosuva 20 | | | OG003 | Placebo | |
| |
| Secondary | Percent Change in LDL-C/HDL-C | Percent change in the ratio of LDL-C/HDL-C after 12 weeks of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | Posted | | Mean | Standard Deviation | mean percent change | | After 12 week of treatment | | | | ID | Title | Description |
|---|
| OG000 | Rosuva 5 | | | OG001 | Rosuva 10 | | | OG002 | Rosuva 20 | | | OG003 | Placebo | |
| |
| Secondary | Percent Change in TC/HDL-C | Percent change in the ratio of TC/HDL-C after 12 weeks of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | Posted | | Mean | Standard Deviation | mean percent change | | After 12 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Rosuva 5 | | | OG001 | Rosuva 10 | | | OG002 | Rosuva 20 | | | OG003 | Placebo | |
| |
| Secondary | Percent Change in Non-HDL-C/HDL-C | Percent change in the ratio of non-HDL-C/HDL-C after 12 weeks of treatment | Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables. | Posted | | Mean | Standard Deviation | mean percent change | | After 12 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Rosuva 5 | | | OG001 | Rosuva 10 | | | OG002 | Rosuva 20 | | | OG003 | Placebo | |
| |