Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
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| ClinicalTrials.gov Identifier: NCT00145574 |
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Recruitment Status :
Completed
First Posted : September 5, 2005
Results First Posted : January 26, 2010
Last Update Posted : April 15, 2010
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Sponsor:
Daiichi Sankyo, Inc.
Information provided by:
Daiichi Sankyo, Inc.
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Hypercholesterolemia |
| Interventions |
Drug: colesevelam HCl Drug: placebo |
| Enrollment | 194 |
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. |
| Arm/Group Title | Placebo | Low Dose Colesevelam | High Dose Colesevelam |
|---|---|---|---|
 Arm/Group Description |
Placebo similar to active | Low dose colesevelam 1.9 grams per day | High dose colesevelam 3.8 grams per day |
| Period Title: Double Blind | |||
| Started | 65 | 65 | 64 |
| Completed | 64 | 60 | 62 |
| Not Completed | 1 | 5 | 2 |
| Reason Not Completed | |||
| Adverse Event | 0 | 3 | 1 |
| Withdrawal by Subject | 1 | 1 | 1 |
| required restricted medicine | 0 | 1 | 0 |
| Period Title: Open Label Long-term Extension | |||
| Started | 0 | 0 | 184 [1] |
| Completed | 0 | 0 | 173 |
| Not Completed | 0 | 0 | 11 |
| Reason Not Completed | |||
| Adverse Event | 0 | 0 | 5 |
| Lost to Follow-up | 0 | 0 | 1 |
| Withdrawal by Subject | 0 | 0 | 4 |
| required restricted medicine | 0 | 0 | 1 |
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[1]
2 participants discontinued after completing double-blind but before starting open label.
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Baseline Characteristics
| Arm/Group Title | Placebo | Low Dose Colesevelam | High Dose Colesevelam | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Placebo similar to active | Low dose colesevelam 1.9 grams per day | High dose colesevelam 3.8 grams per day | Total of all reporting groups | |
| Overall Number of Baseline Participants | 65 | 65 | 64 | 194 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 65 participants | 65 participants | 64 participants | 194 participants | |
| <=18 years |
65 100.0%
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65 100.0%
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64 100.0%
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194 100.0%
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| Between 18 and 65 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| >=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 65 participants | 65 participants | 64 participants | 194 participants | |
| 14.3 (1.74) | 14.1 (2.19) | 13.9 (2.0) | 14.1 (1.98) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 65 participants | 65 participants | 64 participants | 194 participants | |
| Female |
21 32.3%
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26 40.0%
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24 37.5%
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71 36.6%
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| Male |
44 67.7%
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39 60.0%
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40 62.5%
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123 63.4%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 65 participants | 65 participants | 64 participants | 194 participants |
| United States | 16 | 14 | 15 | 45 | |
| Canada | 7 | 9 | 7 | 23 | |
| Austria | 0 | 1 | 0 | 1 | |
| South Africa | 18 | 16 | 17 | 51 | |
| Israel | 6 | 6 | 4 | 16 | |
| Norway | 3 | 3 | 4 | 10 | |
| Netherlands | 3 | 3 | 4 | 10 | |
| Hungary | 6 | 7 | 6 | 19 | |
| New Zealand | 2 | 1 | 2 | 5 | |
| Slovakia | 2 | 0 | 2 | 4 | |
| Czech Republic | 2 | 5 | 3 | 10 | |
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Statin Status
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 65 participants | 65 participants | 64 participants | 194 participants |
| non-naive | 48 | 50 | 49 | 147 | |
| naive | 17 | 15 | 15 | 47 | |
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[1]
Measure Description: Non-naive refers to the number of participants who are taking statins. Naive refers to the number of participants who are not taking statins.
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Tanner Stage
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 65 participants | 65 participants | 64 participants | 194 participants |
| I | 0 | 0 | 0 | 0 | |
| II | 9 | 15 | 15 | 39 | |
| III | 20 | 16 | 16 | 52 | |
| IV | 23 | 19 | 20 | 62 | |
| V | 13 | 15 | 13 | 41 | |
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[1]
Measure Description: Tanner Stage represents a scale measuring physical development in children based on primary and secondary sexual characteristics. The scale has five stages, with Stage I representing prepuberty and Stage 5 representing adult physical development. Please refer to Tanner, JM; Growth at Adolescence, @nd ed. Oxford, England, Blackwell Scientific Publications, 1962 for complete definitions of each Tanner Stage of development.
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Body Mass Index
[1] Mean (Standard Deviation) Unit of measure: Kg/m2 |
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| Number Analyzed | 65 participants | 65 participants | 64 participants | 194 participants | |
| 21.9 (4.30) | 23.4 (6.14) | 22.2 (4.75) | 22.5 (5.14) | ||
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[1]
Measure Description: Body Mass Index (BMI) kg/m2
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height
[1] Mean (Standard Deviation) Unit of measure: Cm |
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| Number Analyzed | 65 participants | 65 participants | 64 participants | 194 participants | |
| 164.8 (10.35) | 160.7 (10.90) | 162.1 (11.94) | 162.5 (11.16) | ||
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[1]
Measure Description: height in centimeters (cm)
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weight
[1] Mean (Standard Deviation) Unit of measure: Kg |
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| Number Analyzed | 65 participants | 65 participants | 64 participants | 194 participants | |
| 60.3 (15.32) | 61.5 (20.77) | 59.0 (16.81) | 60.3 (17.72) | ||
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[1]
Measure Description: mean weight in kilograms (kg) and standard deviation (SD)
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reflects the following restrictive language in the Clinical Study Agreements: "If identified by Daiichi Sankyo,Inc. (DSI), any of DSI's confidential information as defined herein shall be deleted…Nothing in this publication section shall be taken as giving DSI any right of editorial control over any publication prepared by the Study Site."
Results Point of Contact
| Name/Title: | Howard Kessler |
| Organization: | Daiichi Sankyo |
| Phone: | 732-590-5032 |
| EMail: | hmkessler@dsi.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Michael Melino, Daiichi Sankyo |
| ClinicalTrials.gov Identifier: | NCT00145574 |
| Other Study ID Numbers: |
WEL-410 |
| First Submitted: | September 1, 2005 |
| First Posted: | September 5, 2005 |
| Results First Submitted: | November 6, 2009 |
| Results First Posted: | January 26, 2010 |
| Last Update Posted: | April 15, 2010 |