Coronary Arteriosclerosis, Hypercholesterolemia
Conditions
Brief summary
The primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as compared to atorvastatin 10 mg daily in reducing C-reactive protein levels over a 26-week treatment period in subjects with documented coronary artery disease.
Interventions
PROCEDUREBlood samples
DRUGAtorvastatin
Sponsors
MDS Pharma Services
Bio-Inova Life Sciences International
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects of age of majority to \< 80 years * Subjects with LDL-C \> 0.5 g/L (1.29 mmol/L) and \< 1.5 g/L (3.87 mmol/L), TG \< 4.00 g/L (4.56 mmol/L) and hs-CRP \>1.5 mg/L and \< 15 mg/L * Subjects with a documented coronary artery disease.
Exclusion criteria
* Female subjects of childbearing potential without contraception * Subjects with secondary hyperlipidemia * Diabetic subjects receiving insulin * Subjects with a contra-indication to statin therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentages changes of the hs-CRP between baseline (means between week-2 to -1 and week 0 (V2) values) and week 26 (V5). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1/ the percentage change at visit 3 (5-week treatment), visit 4 (13-week-treatment) and visit 5 (26-week treatment) from baseline value in triglycerides, total cholesterol; HDL-cholesterol, LDL-cholesterol, apolipoprotein B 2/ the percentage change at | — |
Countries
Canada, Czechia, France, Poland, Romania, Russia, Slovakia
Outcome results
None listed