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INdians Followed for INtensive Lipid Lowering Treatment and Its safetY

NCT00664469 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2011-07-28

No results posted yet for this study

Summary

In South Asian Canadians with documented coronary artery disease or diabetes and hypercholesterolemia with LDL-C levels \> 2.0 mmol/L after 4 weeks of monotherapy with any statin: To compare the percent (%) of patients who achieve an LDL-C concentration of 2.0mmol/L after a 6-week course of treatment with ezetimibe 10 mg/day co-administered with any statin at any dose versus doubling of the current statin dose.

Conditions

Interventions

DRUG

ezetimibe

ezetimibe 10 mg/day over a 6-week course of treatment.

DRUG

Comparator: Simvastatin 20, 40 and 80 mg

Simvastatin 20, 40 and 80 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.

DRUG

Comparator: Atorvastatin

Atorvastatin 20, 40 \& 80 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.

DRUG

Comparator: Rosuvastatin

Rosuvastatin 10, 20 \& 40 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.

Sponsors & Collaborators

  • Merck Frosst Canada Ltd.

    collaborator INDUSTRY

  • Schering-Plough

    collaborator INDUSTRY

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-03-31
Completion
2010-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00664469 on ClinicalTrials.gov