Colesevelam, Lipids And Sugars, South Asian Canadian Trial (CLASS-ACT)
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|ClinicalTrials.gov Identifier: NCT02504736|
Recruitment Status : Unknown
Verified October 2017 by Canadian Collaborative Research Network.
Recruitment status was: Recruiting
First Posted : July 22, 2015
Last Update Posted : October 27, 2017
|Condition or disease|
This is a prospective, non-controlled, open label, multicenter trial of colesevelam in Canadian South Asian adults at high cardiovascular risk.
- 15-20 clinical sites from Ontario, Quebec, Manitoba and British Columbia will be selected from CCRN's 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 >2.0 mmol/L or non-HDL > 2.6 mmol/L.
- Following informed consent, patients will be screened at baseline for HbA1c, fasting blood glucose, lipid profile, renal function and liver enzymes.
- Baseline demographics, CAD and diabetes documentation and concurrent drug therapy will be collected.
- 250 eligible patients will receive a physician prescription of colesevelam (Lodalis) 625 mg tablets (3 tablets taken twice daily) for 24 weeks.
- Physicians will be requested not to change lipid or diabetes therapy over the 24 week course of the trial.
- 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.
- 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 Type :||Observational|
|Estimated Enrollment :||250 participants|
|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|
|Actual Study Start Date :||June 2015|
|Estimated Primary Completion Date :||February 15, 2018|
|Estimated Study Completion Date :||February 28, 2018|
- The % difference in LDL between baseline and end of study [ Time Frame: 6 months ]
- The % change in HbA1c levels between baseline and end of study [ Time Frame: 6 months ]
- The absolute change in LDL and non-HDL levels between baseline and end of study [ Time Frame: 6 months ]
- 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. [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504736
|Contact: Michelle Tsigoulis||905-453-8885 ext firstname.lastname@example.org|
|Contact: Mahesh P Kajil, MBBS, CCRP||905-453-8885 ext email@example.com|
|Dr. Milan Gupta,MD||Recruiting|
|Brampton, Ontario, Canada, L6Z 4N5|
|Contact: Carmella D Cruz, RN 905-453-8129 firstname.lastname@example.org|
|Principal Investigator:||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|