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| Name | Class |
|---|---|
| Valeant Canada Limited | INDUSTRY |
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To evaluate the effect of colesevelam on LDL levels and A1c in high-risk , dysglycemic South Asians (with diabetes, and/or with CAD and concomitant metabolic syndrome) whose LDL remains above target despite optimal statin use.
This is a prospective, non-controlled, open label, multicenter trial of colesevelam in Canadian South Asian adults at high cardiovascular risk.
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| Measure | Description | Time Frame |
|---|---|---|
| The % difference in LDL between baseline and end of study | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The % change in HbA1c levels between baseline and end of study | 6 months | |
| The absolute change in LDL and non-HDL levels between baseline and end of study | 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals of South Asian ethnicity; self-declared, at least 3 of 4 grandparents born in a South Asian country (i.e. India, Pakistan, Bangladesh, Sri Lanka, Nepal and Bhutan)
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| Name | Affiliation | Role |
|---|---|---|
| Milan K Gupta, MD | McMaster University, Hamilton, ON Canada; University of Toronto, Toronto, ON Canada | Principal Investigator |
| Narendra Singh, MD | Georgia Regents University, Georgia, US | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Milan Gupta,MD | Brampton | Ontario | L6Z 4N5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19237992 | Background | Corsini A, Windler E, Farnier M. Colesevelam hydrochloride: usefulness of a specifically engineered bile acid sequestrant for lowering LDL-cholesterol. Eur J Cardiovasc Prev Rehabil. 2009 Feb;16(1):1-9. doi: 10.1097/HJR.0b013e32831215db. | |
| 21983746 | Background | Aggarwal S, Loomba RS, Arora RR. Efficacy of colesevelam on lowering glycemia and lipids. J Cardiovasc Pharmacol. 2012 Feb;59(2):198-205. doi: 10.1097/FJC.0b013e31823a109f. |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| The safety and tolerability of colesevelam will be determined by the patient reported side/adverse effects and/or hospitalization related to Colesevelam. The side effects will be captured at Visit 3, 4 and 5. |
| 6 months |
| 21437115 | Background | Goldberg RB. Improving glycemic and cholesterol control through an integrated approach incorporating colesevelam - a clinical perspective. Diabetes Metab Syndr Obes. 2009 May 5;2:11-21. doi: 10.2147/dmsott.s3866. |
| 25628509 | Background | Brunetti L, DeSantis EH. Patient tolerance and acceptance of colesevelam hydrochloride: focus on type-2 diabetes mellitus. P T. 2015 Jan;40(1):62-7. |
| 19344229 | Background | Jialal I, Abby SL, Misir S, Nagendran S. Concomitant reduction in low-density lipoprotein cholesterol and glycated hemoglobin with colesevelam hydrochloride in patients with type 2 diabetes: a pooled analysis. Metab Syndr Relat Disord. 2009 Jun;7(3):255-8. doi: 10.1089/met.2009.0007. |
| 18458145 | Background | Fonseca VA, Rosenstock J, Wang AC, Truitt KE, Jones MR. Colesevelam HCl improves glycemic control and reduces LDL cholesterol in patients with inadequately controlled type 2 diabetes on sulfonylurea-based therapy. Diabetes Care. 2008 Aug;31(8):1479-84. doi: 10.2337/dc08-0283. Epub 2008 May 5. |
| 17379048 | Background | Zieve FJ, Kalin MF, Schwartz SL, Jones MR, Bailey WL. Results of the glucose-lowering effect of WelChol study (GLOWS): a randomized, double-blind, placebo-controlled pilot study evaluating the effect of colesevelam hydrochloride on glycemic control in subjects with type 2 diabetes. Clin Ther. 2007 Jan;29(1):74-83. doi: 10.1016/j.clinthera.2007.01.003. |