Colesevelam, Lipids And Sugars, South Asian Canadian Trial (CLASS-ACT)

January 22, 2020 updated by: Canadian Collaborative Research Network

24 Week Open Label, Single Arm Study of Colesevelam in High Risk South Asians With Suboptimal LDL-c Levels Despite Maximally Tolerated Statin Therapy

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.

Study Overview

Status

Completed

Conditions

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 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.
  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 Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6Z 4N5
        • Dr. Milan Gupta,MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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)

Description

Inclusion Criteria:

  • 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)
  • Either Diabetes, or Coronary artery disease with metabolic syndrome
  • Currently receiving maximally tolerated dose of statin therapy (at least Atorvastatin 20 mg or Rosuvastatin 10 mg)
  • LDL >2.0 mmol/L or non-HDL >2.6 mmol/L
  • Patient is willing to provide written consent
  • Age ≥ 18 years

Exclusion Criteria:

  • Receiving lipid-lowering agents, other than statins or ezetimibe
  • Any changes made to current lipid lowering therapy in the last 12 weeks
  • Uncontrolled diabetes (HbA1c >0.10)
  • TG > 5.0 mmol/L
  • Significant hepatic or renal disease (ALT > 2x ULN or eGFR < 30 mL/min/1.73 m²)
  • Ongoing participation in any randomized clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The % difference in LDL between baseline and end of study
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The % change in HbA1c levels between baseline and end of study
Time Frame: 6 months
6 months
The absolute change in LDL and non-HDL levels between baseline and end of study
Time Frame: 6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Collaborative Research Network

Collaborators

Valeant Canada Limited

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

February 15, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

July 13, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLASS ACT-24-FEB-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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