DyslipidemiaCLASS-ACTNCT02504736
Colesevelam, Lipids And Sugars, South Asian Canadian Trial
An observational study of Dyslipidemia, run by Canadian Collaborative Research Network at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to 28 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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.
- Conditions
- Dyslipidemia
- Keywords
- LDL cholesterol, A1c, High risk South Asians, Colesevelam
- Medical subject headings
- Dyslipidemias
What is being measured
The primary outcome is the main question the study is designed to answer.
The % difference in LDL between baseline and end of study
Measured: 6 months
Secondary outcomes (3)
The % change in HbA1c levels between baseline and end of study
Measured: 6 months
The absolute change in LDL and non-HDL levels between baseline and end of study
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJun 2015
- Primary completion15 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Collaborative Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Valeant Canada Limited
- Responsible party
- Sponsor
- Investigators
- Milan K Gupta, MD, Principal investigator, McMaster University, Hamilton, ON Canada; University of Toronto, Toronto, ON CanadaNarendra Singh, MD, Principal investigator, Georgia Regents University, Georgia, US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504736
- Sponsor's protocol ID
- CLASS ACT-24-FEB-2015
- Acronym
- CLASS-ACT
- Status last verified
- Jan 2020
- First submitted
- 13 Jul 2015
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19237992Aggarwal 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.
PubMed 21983746Goldberg 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.
PubMed 21437115Brunetti L, DeSantis EH. Patient tolerance and acceptance of colesevelam hydrochloride: focus on type-2 diabetes mellitus. P T. 2015 Jan;40(1):62-7.
PubMed 25628509Jialal 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.
PubMed 19344229Fonseca 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.
PubMed 18458145Zieve 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.
PubMed 17379048
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02504736
- Acronym / sponsor ID
- CLASS-ACT / CLASS ACT-24-FEB-2015
- Conditions
- Dyslipidemia
- Keywords
- LDL cholesterol, A1c, High risk South Asians, Colesevelam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Canadian Collaborative Research NetworkUniversity, hospital or other
- Collaborators
- Valeant Canada Limited
- Study start
- Jun 2015 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The % difference in LDL between baseline and end of study
Time frame: 6 months
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Background: PubMed 19237992Corsini 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.
- Background: PubMed 21983746Aggarwal 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.
- Background: PubMed 21437115Goldberg 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.
- Background: PubMed 25628509Brunetti L, DeSantis EH. Patient tolerance and acceptance of colesevelam hydrochloride: focus on type-2 diabetes mellitus. P T. 2015 Jan;40(1):62-7.
- Background: PubMed 19344229Jialal 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.
- Background: PubMed 18458145Fonseca 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.
- Background: PubMed 17379048Zieve 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.
Related trials for Dyslipidemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milan K Gupta, MD principal investigator
McMaster University, Hamilton, ON Canada; University of Toronto, Toronto, ON Canada
Narendra Singh, MD principal investigator
Georgia Regents University, Georgia, US
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemia, run by Canadian Collaborative Research Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The % difference in LDL between baseline and end of study (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02504736, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.