Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Valeant Canada Limited
Information provided by (Responsible Party):
Canadian Collaborative Research Network

Brief 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.

Condition or disease
Dyslipidemia

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The % difference in LDL between baseline and end of study [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The % change in HbA1c levels between baseline and end of study [ Time Frame: 6 months ]
  2. The absolute change in LDL and non-HDL levels between baseline and end of study [ Time Frame: 6 months ]
  3. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Michelle Tsigoulis 905-453-8885 ext 428 mtsigoulis@ccrnmd.com
Contact: Mahesh P Kajil, MBBS, CCRP 905-453-8885 ext 414 mkajil@ccrnmd.com

Locations
Layout table for location information
Canada, Ontario
Dr. Milan Gupta,MD Recruiting
Brampton, Ontario, Canada, L6Z 4N5
Contact: Carmella D Cruz, RN    905-453-8129    cdelacruz@bramptonresearch.ca   
Sponsors and Collaborators
Canadian Collaborative Research Network
Valeant Canada Limited
Investigators
Layout table for investigator information
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:

Layout table for additonal information
Responsible Party: Canadian Collaborative Research Network
ClinicalTrials.gov Identifier: NCT02504736     History of Changes
Other Study ID Numbers: CLASS ACT-24-FEB-2015
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Keywords provided by Canadian Collaborative Research Network:
LDL cholesterol
A1c
High risk South Asians
Colesevelam
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents