Phase 4
N=194
Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT00145574 ↗Enrolled (actual)
194
Serious AEs
1.6%
Results posted
Jan 2010
Primary outcome: Primary: Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8. — 2.9; -3.7; -10.6 percent change from baseline — p=0.1122
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- colesevelam HCl (Drug); placebo (Drug)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8. |
2.9; -3.7; -10.6 | 0.1122 |
| SECONDARY Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8. |
2.9; -1.1; -5.4 | 0.5260 |
| SECONDARY Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8. |
12.5; 16.9; 12.5 | <0.0001 sig |
| SECONDARY Percent Change in Plasma High-density Lipoprotein-cholesterol (HDL-C) From Day 1 (Study Baseline) to Week 8. |
2.5; 3.9; 8.5 | 0.0155 sig |
| SECONDARY Percent Change in Plasma Non-high Density Lipoprotein-cholesterol (Non-HDL-C) From Day 1 (Study Baseline) to Week 8. |
3.4; -2.1; -8.4 | 0.3482 |
| SECONDARY Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8. |
4.4; 7.0; 11.2 | 0.0002 sig |
| SECONDARY Percent Change in Plasma Apolipoprotein B (Apo B) From Day 1 (Study Baseline) to Week 8. |
2.3; -0.7; -7.0 | 0.7433 |
| SECONDARY Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Study Baseline (Day 1) to Week 26. |
-11.9; -16.8; -13.5; -14.0 | — |
| SECONDARY Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26. |
-7.5; -9.1; -7.5; -8.0 | — |
| SECONDARY Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26. |
-5.3; 19.5; 14.2; 11.5 | — |
| SECONDARY Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Study Baseline (Day 1) to Week 26. |
6.6; 8.5; 9.3; 8.1 | — |
| SECONDARY Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26. |
-10.0; -13.2; -11.0; -11.3 | — |
| SECONDARY Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26. |
4.7; 4.9; 7.2; 5.6 | — |
| SECONDARY Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26. |
-11.4; -11.3; -11.2; -11.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00145574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.