Ignite Creation Date:
2024-05-06 @ 7:17 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02504736
Status:
COMPLETED
Last Update Posted:
2020-01-23
First Post:
2015-07-13
Brief Title:
Colesevelam Lipids And Sugars South Asian Canadian Trial
Sponsor:
Canadian Collaborative Research Network
Organization:
Canadian Collaborative Research Network
Study Overview
Official Title:
24 Week Open Label Single Arm Study of Colesevelam in High Risk South Asians With Suboptimal LDL-c Levels Despite Maximally Tolerated Statin Therapy
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLASS-ACT
Brief Summary:
To evaluate the effect of colesevelam on LDL levels and A1c in high-risk dysglycemic South Asians with diabetes andor with CAD and concomitant metabolic syndrome whose LDL remains above target despite optimal statin use
Detailed Description:
This is a prospective non-controlled open label multicenter trial of colesevelam in Canadian South Asian adults at high cardiovascular risk
1 15-20 clinical sites from Ontario Quebec Manitoba and British Columbia will be selected from CCRNs network of primary care physicians and cardiologists to identify patients having stable type 2 diabetes or documented stable CAD with metabolic syndrome who are on maximally tolerated statin therapy with LDL 20 mmolL or non-HDL 26 mmolL
2 Following informed consent patients will be screened at baseline for HbA1c fasting blood glucose lipid profile renal function and liver enzymes
3 Baseline demographics CAD and diabetes documentation and concurrent drug therapy will be collected
4 250 eligible patients will receive a physician prescription of colesevelam Lodalis 625 mg tablets 3 tablets taken twice daily for 24 weeks
5 Physicians will be requested not to change lipid or diabetes therapy over the 24 week course of the trial
6 Patients will be contacted at 2 and 12 weeks visit 3 and 4 via a phone call to assess adherence to the prescribed therapy review other concurrent medications and assess for any adverse events
7 The week 24 visit study visit 5 will include collection of fasting blood work as per screening visit review of concurrent drug therapy and a final assessment for any adverse events
1 15-20 clinical sites from Ontario Quebec Manitoba and British Columbia will be selected from CCRNs network of primary care physicians and cardiologists to identify patients having stable type 2 diabetes or documented stable CAD with metabolic syndrome who are on maximally tolerated statin therapy with LDL 20 mmolL or non-HDL 26 mmolL
2 Following informed consent patients will be screened at baseline for HbA1c fasting blood glucose lipid profile renal function and liver enzymes
3 Baseline demographics CAD and diabetes documentation and concurrent drug therapy will be collected
4 250 eligible patients will receive a physician prescription of colesevelam Lodalis 625 mg tablets 3 tablets taken twice daily for 24 weeks
5 Physicians will be requested not to change lipid or diabetes therapy over the 24 week course of the trial
6 Patients will be contacted at 2 and 12 weeks visit 3 and 4 via a phone call to assess adherence to the prescribed therapy review other concurrent medications and assess for any adverse events
7 The week 24 visit study visit 5 will include collection of fasting blood work as per screening visit review of concurrent drug therapy and a final assessment for any adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None