drugset / Trial / NCT00664469
INdians Followed for INtensive Lipid Lowering Treatment and Its safetY
Phase 3
Terminated
64 enrolled
Sunnybrook Health Sciences Centre
Merck Frosst Canada Ltd. · collabSchering-Plough · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-08
- Primary completion
- 2010-03
- Completion
- 2010-11
Outcome
Outcome not reported
Stopped (Enrollment): “Poor enrollment”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atorvastatin | Small molecule | 20 mg | — |
| Comparator | Atorvastatin | Small molecule | 40 mg | — |
| Comparator | Atorvastatin | Small molecule | 80 mg | — |
| Subject | Ezetimibe | Unknown | 10 mg | — |
| Comparator | Rosuvastatin | Small molecule | 10 mg | — |
| Comparator | Rosuvastatin | Small molecule | 20 mg | — |
| Comparator | Rosuvastatin | Small molecule | 40 mg | — |
| Comparator | Simvastatin | Small molecule | 20 mg | — |
| Comparator | Simvastatin | Small molecule | 40 mg | — |
| Comparator | Simvastatin | Small molecule | 80 mg | — |