Hypercholesteremia
Conditions
Keywords
Hypercholesteremia
Brief summary
The purpose of this trial is to see if rosuvastatin will be effective in decreasing the thickness of the walls of the arteries in the neck for people who already have some evidence of thickening of these walls.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Maximum IMT \>1.2 mm and 3.5 mm at any location in the carotid ultrasound studies conducted at both Visit 2 (Week -4) and Visit 3 (Week -2) * Subjects with age and no other risk factor: Fasting LDL-C at Visit 1 (Week -6) is \>120 mg/dL (3.1mmol/L) and \<190 mg/dL (4.9 mmol/L) * Subjects with 2 or more risk factors and a 10-year coronary heart disease (CHD) risk \< 10%: Fasting LDL-C at Visit 1 (Week -6) is \>120 mg/dL (3.1 mmol/L) and \<160 mg/dL (4.1 mmol/L)
Exclusion criteria
* Use of pharmacologic lipid-lowering medications (eg, HMG-CoA reductase inhibitors, fibrate derivatives, bile acid binding resins, niacin or its analogues at doses \>400 mg) within 12 months prior to Visit 1 (Week -6). * Clinical evidence of coronary artery disease or any other atherosclerotic disease such as angina, MI, TIA, symptomatic carotid artery disease, CVA, CABG, PTCA, peripheral arterial disease, AAA.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the effects of rosuvastatin treatment on the change in the mean maximum intima media thickness (IMT) of the 12 vessel segments: the near & far walls of the CCA, the carotid bulb & the ICA | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the mean maximum IMT of the near & far walls of the right & left CCA, carotid bulb, ICA | — |
| Change in the mean IMT of the near & far walls of the right & left CCA | — |
| Assess the effects of rosuvastatin treatment on the following variables, with the same analyses being applied to the IMT variables: | — |
| Change in inflammatory marker: C-reactive protein (CRP) | — |
| Safety & tolerability, by evaluating the incidence & severity of adverse events & abnormal laboratory values | — |
| Change in LDL-C, TC, HDL-C, TG, nonHDL-C, ApoB, ApoA-I, nonHDL-C/HDL-C, & ApoB/ApoA-I | — |
Countries
Belgium, Czechia, Finland, France, Germany, Netherlands, Norway, United States
Outcome results
None listed