Hypercholesterolemia
Conditions
Keywords
Pediatric, hypercholesterolemia, colesevelam
Brief summary
This study will evaluate the lipid-lowering effect and safety of colesevelam therapy administered to heterozygous familial pediatric patients 10 through 17 years of age who are on a stable dose of a pediatric-approved statin monotherapy (atorvastatin, lovastatin, simvastatin or pravastatin), or who are treatment naive to lipid-lowering therapy.
Interventions
DRUGcolesevelam HCl
Tablets
DRUGplacebo
Matching Tablets
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients * Ages 10 to 17 years inclusive * Diagnosis of heterozygous familial hypercholesterolemia * On a stable dose of statin monotherapy or are treatment naive to lipid- lowering agents * On a low-cholesterol diet
Exclusion criteria
* Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8. | 8 weeks (week 8 - day 1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8. | 8 weeks (week 8 - day 1) | 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. |
| Percent Change in Plasma High-density Lipoprotein-cholesterol (HDL-C) From Day 1 (Study Baseline) to Week 8. | 8 weeks (week 8 - day 1) | 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. |
| Percent Change in Plasma Non-high Density Lipoprotein-cholesterol (Non-HDL-C) From Day 1 (Study Baseline) to Week 8. | 8 weeks (week 8 - day 1) | 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. |
| Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8. | 8 weeks (week 8 - day 1) | 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. |
| Percent Change in Plasma Apolipoprotein B (Apo B) From Day 1 (Study Baseline) to Week 8. | 8 weeks (week 8 - day 1) | 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. |
| Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Study Baseline (Day 1) to Week 26. | 26 weeks (week 26 - day 1) | 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. |
| Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8. | 8 weeks (week 8 - day 1) | 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. |
| Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26. | 26 weeks (week 26 - day 1) | 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. |
| Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Study Baseline (Day 1) to Week 26. | 26 weeks (week 26 - day 1) | 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. |
| Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26. | 26 weeks (week 26 - day 1) | 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. |
| Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26. | 26 weeks (week 26 - day 1) | 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. |
| Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26. | 26 weeks (week 26 - day 1) | 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. |
| Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26. | 26 weeks (week 26 - day 1) | 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. |
Countries
Australia, Austria, Canada, Israel, Netherlands, Norway, South Africa, United States
Participant flow
Recruitment details
Study was conducted at 41 clinical sites; Australia (1 site), Austria (1 site), Canada (5 sites), Hungary (1 site), Israel (5 sites), New Zealand (1 site), Norway (2 sites), Slovakia (3 sites), South Africa (4 sites), Czech Republic (3 sites), Netherlands (2 sites), and USA (13 sites). Study initiated November 5, 2005 completed December 18, 2007.
Pre-assignment details
Period I Run-In (4 weeks): Period I was a single-blind stabilization period prior to randomization. All subjects received 6 placebo tablets daily. Objective was to evaluate dosing compliance and tolerability to the tablets prior to randomization. Subjects could be on stable pediatric approved statin regimen and low cholesterol diet for 6 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo similar to active | 65 |
| Low Dose Colesevelam Low dose colesevelam 1.9 grams per day | 65 |
| High Dose Colesevelam High dose colesevelam 3.8 grams per day | 64 |
| Total | 194 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double Blind | Adverse Event | 0 | 3 | 1 |
| Double Blind | required restricted medicine | 0 | 1 | 0 |
| Double Blind | Withdrawal by Subject | 1 | 1 | 1 |
| Open Label Long-term Extension | Adverse Event | 0 | 0 | 5 |
| Open Label Long-term Extension | Lost to Follow-up | 0 | 0 | 1 |
| Open Label Long-term Extension | required restricted medicine | 0 | 0 | 1 |
| Open Label Long-term Extension | Withdrawal by Subject | 0 | 0 | 4 |
Baseline characteristics
| Characteristic | Low Dose Colesevelam | Total | Placebo | High Dose Colesevelam |
|---|---|---|---|---|
| Age, Categorical <=18 years | 65 Participants | 194 Participants | 65 Participants | 64 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 14.1 years STANDARD_DEVIATION 2.19 | 14.1 years STANDARD_DEVIATION 1.98 | 14.3 years STANDARD_DEVIATION 1.74 | 13.9 years STANDARD_DEVIATION 2 |
| Body Mass Index | 23.4 kg/m2 STANDARD_DEVIATION 6.14 | 22.5 kg/m2 STANDARD_DEVIATION 5.14 | 21.9 kg/m2 STANDARD_DEVIATION 4.3 | 22.2 kg/m2 STANDARD_DEVIATION 4.75 |
| height | 160.7 cm STANDARD_DEVIATION 10.9 | 162.5 cm STANDARD_DEVIATION 11.16 | 164.8 cm STANDARD_DEVIATION 10.35 | 162.1 cm STANDARD_DEVIATION 11.94 |
| Region of Enrollment Austria | 1 participants | 1 participants | 0 participants | 0 participants |
| Region of Enrollment Canada | 9 participants | 23 participants | 7 participants | 7 participants |
| Region of Enrollment Czech Republic | 5 participants | 10 participants | 2 participants | 3 participants |
| Region of Enrollment Hungary | 7 participants | 19 participants | 6 participants | 6 participants |
| Region of Enrollment Israel | 6 participants | 16 participants | 6 participants | 4 participants |
| Region of Enrollment Netherlands | 3 participants | 10 participants | 3 participants | 4 participants |
| Region of Enrollment New Zealand | 1 participants | 5 participants | 2 participants | 2 participants |
| Region of Enrollment Norway | 3 participants | 10 participants | 3 participants | 4 participants |
| Region of Enrollment Slovakia | 0 participants | 4 participants | 2 participants | 2 participants |
| Region of Enrollment South Africa | 16 participants | 51 participants | 18 participants | 17 participants |
| Region of Enrollment United States | 14 participants | 45 participants | 16 participants | 15 participants |
| Sex: Female, Male Female | 26 Participants | 71 Participants | 21 Participants | 24 Participants |
| Sex: Female, Male Male | 39 Participants | 123 Participants | 44 Participants | 40 Participants |
| Statin Status naive | 15 participants | 47 participants | 17 participants | 15 participants |
| Statin Status non-naive | 50 participants | 147 participants | 48 participants | 49 participants |
| Tanner Stage I | 0 participants | 0 participants | 0 participants | 0 participants |
| Tanner Stage II | 15 participants | 39 participants | 9 participants | 15 participants |
| Tanner Stage III | 16 participants | 52 participants | 20 participants | 16 participants |
| Tanner Stage IV | 19 participants | 62 participants | 23 participants | 20 participants |
| Tanner Stage V | 15 participants | 41 participants | 13 participants | 13 participants |
| weight | 61.5 kg STANDARD_DEVIATION 20.77 | 60.3 kg STANDARD_DEVIATION 17.72 | 60.3 kg STANDARD_DEVIATION 15.32 | 59.0 kg STANDARD_DEVIATION 16.81 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 20 / 65 | 25 / 65 | 14 / 64 | 71 / 184 |
| serious Total, serious adverse events | 3 / 65 | 3 / 65 | 0 / 64 | 0 / 184 |
Outcome results
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.
Time frame: 8 weeks (week 8 - day 1)
Population: Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8. | 2.9 percent change from baseline | Standard Deviation 16.46 |
| Low Dose Colesevelam | Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8. | -3.7 percent change from baseline | Standard Deviation 18.36 |
| High Dose Colesevelam | Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8. | -10.6 percent change from baseline | Standard Deviation 19.36 |
Comparison: 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%.p-value: 0.1122ANCOVA
p-value: <0.0001ANCOVA
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.
Time frame: 26 weeks (week 26 - day 1)
Population: Intent to treat population. Last Observation Carried Forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26. | 4.7 percent change from baseline | Standard Deviation 12.95 |
| Low Dose Colesevelam | Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26. | 4.9 percent change from baseline | Standard Deviation 14.86 |
| High Dose Colesevelam | Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26. | 7.2 percent change from baseline | Standard Deviation 15.34 |
| All High Dose Colesevelam in Open Label Extension | Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26. | 5.6 percent change from baseline | Standard Deviation 14.4 |
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.
Time frame: 26 weeks (week 26 - day 1)
Population: Intent to treat population. Last Observation Carried Forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26. | -11.4 percent change from baseline | Standard Deviation 16.86 |
| Low Dose Colesevelam | Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26. | -11.3 percent change from baseline | Standard Deviation 18.71 |
| High Dose Colesevelam | Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26. | -11.2 percent change from baseline | Standard Deviation 17.86 |
| All High Dose Colesevelam in Open Label Extension | Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26. | -11.3 percent change from baseline | Standard Deviation 17.72 |
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.
Time frame: 26 weeks (week 26 - day 1)
Population: Intent to treat population. Last Observation Carried Forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Study Baseline (Day 1) to Week 26. | 6.6 percent change from baseline | Standard Deviation 13.64 |
| Low Dose Colesevelam | Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Study Baseline (Day 1) to Week 26. | 8.5 percent change from baseline | Standard Deviation 20.33 |
| High Dose Colesevelam | Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Study Baseline (Day 1) to Week 26. | 9.3 percent change from baseline | Standard Deviation 19.37 |
| All High Dose Colesevelam in Open Label Extension | Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Study Baseline (Day 1) to Week 26. | 8.1 percent change from baseline | Standard Deviation 17.86 |
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.
Time frame: 26 weeks (week 26 - day 1)
Population: Intent-to-Treat (ITT) Population. Last Observation Carried Forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Study Baseline (Day 1) to Week 26. | -11.9 percent change from baseline | Standard Deviation 22.39 |
| Low Dose Colesevelam | Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Study Baseline (Day 1) to Week 26. | -16.8 percent change from baseline | Standard Deviation 19.85 |
| High Dose Colesevelam | Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Study Baseline (Day 1) to Week 26. | -13.5 percent change from baseline | Standard Deviation 21.58 |
| All High Dose Colesevelam in Open Label Extension | Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Study Baseline (Day 1) to Week 26. | -14.0 percent change from baseline | Standard Deviation 21.32 |
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.
Time frame: 26 weeks (week 26 - day 1)
Population: Intent to treat population. Last Observation Carried Forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26. | -10.0 percent change from baseline | Standard Deviation 21.04 |
| Low Dose Colesevelam | Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26. | -13.2 percent change from baseline | Standard Deviation 19.9 |
| High Dose Colesevelam | Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26. | -11.0 percent change from baseline | Standard Deviation 20.8 |
| All High Dose Colesevelam in Open Label Extension | Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26. | -11.3 percent change from baseline | Standard Deviation 20.53 |
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.
Time frame: 8 weeks (week 8 - day 1)
Population: Intent-to-Treat (ITT) Population in Double blind Period. Last Observation Carried Forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Plasma Apolipoprotein B (Apo B) From Day 1 (Study Baseline) to Week 8. | 2.3 percent change from baseline | Standard Deviation 14.78 |
| Low Dose Colesevelam | Percent Change in Plasma Apolipoprotein B (Apo B) From Day 1 (Study Baseline) to Week 8. | -0.7 percent change from baseline | Standard Deviation 16.52 |
| High Dose Colesevelam | Percent Change in Plasma Apolipoprotein B (Apo B) From Day 1 (Study Baseline) to Week 8. | -7.0 percent change from baseline | Standard Deviation 14.45 |
p-value: 0.7433ANCOVA
p-value: 0.0003ANCOVA
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.
Time frame: 8 weeks (week 8 - day 1)
Population: Intent-to-Treat (ITT) Population in Double blind Period. Last Observation Carried Forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8. | 4.4 percent change from baseline | Standard Deviation 14.62 |
| Low Dose Colesevelam | Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8. | 7.0 percent change from baseline | Standard Deviation 13.96 |
| High Dose Colesevelam | Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8. | 11.2 percent change from baseline | Standard Deviation 16.79 |
p-value: 0.0002ANCOVA
p-value: <0.0001ANCOVA
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.
Time frame: 8 weeks (week 8 - day 1)
Population: Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Plasma High-density Lipoprotein-cholesterol (HDL-C) From Day 1 (Study Baseline) to Week 8. | 2.5 percent change from baseline | Standard Deviation 12.52 |
| Low Dose Colesevelam | Percent Change in Plasma High-density Lipoprotein-cholesterol (HDL-C) From Day 1 (Study Baseline) to Week 8. | 3.9 percent change from baseline | Standard Deviation 12.45 |
| High Dose Colesevelam | Percent Change in Plasma High-density Lipoprotein-cholesterol (HDL-C) From Day 1 (Study Baseline) to Week 8. | 8.5 percent change from baseline | Standard Deviation 14.72 |
p-value: 0.0155ANCOVA
p-value: <0.0001ANCOVA
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.
Time frame: 8 weeks (week 8 - day 1)
Population: Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Plasma Non-high Density Lipoprotein-cholesterol (Non-HDL-C) From Day 1 (Study Baseline) to Week 8. | 3.4 percent change from baseline | Standard Deviation 16.01 |
| Low Dose Colesevelam | Percent Change in Plasma Non-high Density Lipoprotein-cholesterol (Non-HDL-C) From Day 1 (Study Baseline) to Week 8. | -2.1 percent change from baseline | Standard Deviation 17.32 |
| High Dose Colesevelam | Percent Change in Plasma Non-high Density Lipoprotein-cholesterol (Non-HDL-C) From Day 1 (Study Baseline) to Week 8. | -8.4 percent change from baseline | Standard Deviation 18.28 |
p-value: 0.3482ANCOVA
p-value: 0.0006ANCOVA
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.
Time frame: 8 weeks (week 8 - day 1)
Population: Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8. | 2.9 percent change from baseline | Standard Deviation 13.29 |
| Low Dose Colesevelam | Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8. | -1.1 percent change from baseline | Standard Deviation 14.22 |
| High Dose Colesevelam | Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8. | -5.4 percent change from baseline | Standard Deviation 15.8 |
p-value: 0.526ANCOVA
p-value: 0.0085ANCOVA
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.
Time frame: 8 weeks (week 8 - day 1)
Population: Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8. | 12.5 percent change from baseline | Standard Deviation 40.8 |
| Low Dose Colesevelam | Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8. | 16.9 percent change from baseline | Standard Deviation 35.7 |
| High Dose Colesevelam | Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8. | 12.5 percent change from baseline | Standard Deviation 53.2 |
p-value: <0.0001ANCOVA
p-value: 0.0008ANCOVA
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.
Time frame: 26 weeks (week 26 - day 1)
Population: Intent to treat population. Last Observation Carried Forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26. | -7.5 percent change from baseline | Standard Deviation 17.21 |
| Low Dose Colesevelam | Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26. | -9.1 percent change from baseline | Standard Deviation 16.91 |
| High Dose Colesevelam | Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26. | -7.5 percent change from baseline | Standard Deviation 17.55 |
| All High Dose Colesevelam in Open Label Extension | Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26. | -8.0 percent change from baseline | Standard Deviation 17.15 |
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.
Time frame: 26 weeks (week 26 - day 1)
Population: Intent to treat population. Last Observation Carried Forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26. | -5.3 percent change from baseline | Standard Deviation 59.1 |
| Low Dose Colesevelam | Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26. | 19.5 percent change from baseline | Standard Deviation 58 |
| High Dose Colesevelam | Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26. | 14.2 percent change from baseline | Standard Deviation 64.5 |
| All High Dose Colesevelam in Open Label Extension | Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26. | 11.5 percent change from baseline | Standard Deviation 61.8 |