| Primary | Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8. | Percent change in LDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline)to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population. | Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward. | Posted | Nov 2009 | Mean | Standard Deviation | percent change from baseline | | 8 weeks (week 8 - day 1) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo similar to active | | OG001 | Low Dose Colesevelam | Low dose colesevelam 1.9 grams per day | | OG002 | High Dose Colesevelam | High dose colesevelam 3.8 grams per day |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0002.9± 16.46
- OG001-3.7± 18.36
- OG002-10.6± 19.36
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The primary null hypotheses were tested sequentially in the following order: 1) no difference between the high-dose colesevelam HCl and placebo for percent change in LDL-C from study baseline to Week 8 endpoint with the last observation carried forward (LOCF) and 2) no difference between the low-dose colesevelam HCl and placebo for percent change in LDL-C from study baseline to Week 8 endpoint with LOCF. The hypotheses were tested at a 2-sided significance level of 5%. | ANCOVA | | 0.1122 | | | | | | | | | | | | | No | Superiority or Other | | |
|
| Secondary | Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8. | Percent change in total cholesterol (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population. | Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward. | Posted | Nov 2009 | Mean | Standard Deviation | percent change from baseline | | 8 weeks (week 8 - day 1) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo similar to active | | OG001 | Low Dose Colesevelam | Low dose colesevelam 1.9 grams per day | | OG002 | High Dose Colesevelam | High dose colesevelam 3.8 grams per day |
| |
| Secondary | Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8. | Percent change in triglycerides (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population. | Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward. | Posted | Nov 2009 | Mean | Standard Deviation | percent change from baseline | | 8 weeks (week 8 - day 1) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo similar to active | | OG001 | Low Dose Colesevelam | Low dose colesevelam 1.9 grams per day | | OG002 | High Dose Colesevelam | High dose colesevelam 3.8 grams per day |
| |
| Secondary | Percent Change in Plasma High-density Lipoprotein-cholesterol (HDL-C) From Day 1 (Study Baseline) to Week 8. | Percent change in HDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population. | Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward. | Posted | Nov 2009 | Mean | Standard Deviation | percent change from baseline | | 8 weeks (week 8 - day 1) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo similar to active | | OG001 | Low Dose Colesevelam | Low dose colesevelam 1.9 grams per day | | OG002 | High Dose Colesevelam | High dose colesevelam 3.8 grams per day |
| |
| Secondary | Percent Change in Plasma Non-high Density Lipoprotein-cholesterol (Non-HDL-C) From Day 1 (Study Baseline) to Week 8. | Percent change in non-HDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population. | Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward. | Posted | Nov 2009 | Mean | Standard Deviation | percent change from baseline | | 8 weeks (week 8 - day 1) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo similar to active | | OG001 | Low Dose Colesevelam | Low dose colesevelam 1.9 grams per day | | OG002 | High Dose Colesevelam | High dose colesevelam 3.8 grams per day |
| |
| Secondary | Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8. | Percent change in Apolipoprotien A-I (Apo A-1) (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population. | Intent-to-Treat (ITT) Population in Double blind Period. Last Observation Carried Forward. | Posted | Nov 2009 | Mean | Standard Deviation | percent change from baseline | | 8 weeks (week 8 - day 1) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo similar to active | | OG001 | Low Dose Colesevelam | Low dose colesevelam 1.9 grams per day | | OG002 | High Dose Colesevelam | High dose colesevelam 3.8 grams per day |
| |
| Secondary | Percent Change in Plasma Apolipoprotein B (Apo B) From Day 1 (Study Baseline) to Week 8. | Percent change in Apo B (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population. | Intent-to-Treat (ITT) Population in Double blind Period. Last Observation Carried Forward. | Posted | Nov 2009 | Mean | Standard Deviation | percent change from baseline | | 8 weeks (week 8 - day 1) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo similar to active | | OG001 | Low Dose Colesevelam | Low dose colesevelam 1.9 grams per day | | OG002 | High Dose Colesevelam | High dose colesevelam 3.8 grams per day |
| |
| Secondary | Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Study Baseline (Day 1) to Week 26. | Percent change in low-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period. | Intent-to-Treat (ITT) Population. Last Observation Carried Forward. | Posted | Nov 2009 | Mean | Standard Deviation | percent change from baseline | | 26 weeks (week 26 - day 1) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period. | | OG001 | Low Dose Colesevelam | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period. | | OG002 | High Dose Colesevelam | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period. |
|
| Secondary | Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26. | Percent change in total cholesterol (TC) from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period. | Intent to treat population. Last Observation Carried Forward. | Posted | Nov 2009 | Mean | Standard Deviation | percent change from baseline | | 26 weeks (week 26 - day 1) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period. | | OG001 | Low Dose Colesevelam | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period. | | OG002 | High Dose Colesevelam | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period. |
|
| Secondary | Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26. | Percent change in triglycerides from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period. | Intent to treat population. Last Observation Carried Forward. | Posted | Nov 2009 | Mean | Standard Deviation | percent change from baseline | | 26 weeks (week 26 - day 1) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period. | | OG001 | Low Dose Colesevelam | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period. | | OG002 | High Dose Colesevelam | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period. |
|
| Secondary | Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Study Baseline (Day 1) to Week 26. | Percent change in high-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period. | Intent to treat population. Last Observation Carried Forward. | Posted | Nov 2009 | Mean | Standard Deviation | percent change from baseline | | 26 weeks (week 26 - day 1) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period. | | OG001 | Low Dose Colesevelam | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period. | | OG002 | High Dose Colesevelam | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period. |
|
| Secondary | Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26. | Percent change in non-high-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period. | Intent to treat population. Last Observation Carried Forward. | Posted | Nov 2009 | Mean | Standard Deviation | percent change from baseline | | 26 weeks (week 26 - day 1) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period. | | OG001 | Low Dose Colesevelam | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period. | | OG002 | High Dose Colesevelam | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period. |
|
| Secondary | Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26. | Percent change in apolipoprotein A-I from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period. | Intent to treat population. Last Observation Carried Forward. | Posted | Nov 2009 | Mean | Standard Deviation | percent change from baseline | | 26 weeks (week 26 - day 1) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period. | | OG001 | Low Dose Colesevelam | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period. | | OG002 | High Dose Colesevelam | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period. |
|
| Secondary | Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26. | Percent change in apolipoprotein B from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period. | Intent to treat population. Last Observation Carried Forward. | Posted | Nov 2009 | Mean | Standard Deviation | percent change from baseline | | 26 weeks (week 26 - day 1) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period. | | OG001 | Low Dose Colesevelam | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period. | | OG002 | High Dose Colesevelam | A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period. |
|