A phase3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects With Subclinical Atherosclerosis

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Atherosclerosis

Treatments: Drug: Placebo; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02546323

D3565C00003

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of of rosuvastatin 20 mg compared to placebo for treating Chinese patients with subclinical atherosclerosis.

Full description

This study is a randomized, double-blind, placebo-controlled, multicenter parallel group study assessing the effects of rosuvastatin 20 mg treatment for 104 weeks on the change in intimamedia thickness (IMT) of the common carotid artery (CCA), carotid bulb, and internal carotid artery (ICA) in adult Chinese subjects with subclinical atherosclerosis.

Enrollment: 543 patients

Sex: All

Ages: 45 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of informed consent prior to any study-specific procedures
• Male aged ≥45 and <70 years or female aged ≥55 and <70 years
• Subjects with only hypertension (as defined blood pressure ≥140/90 mmHg or on antihypertensive treatment) and age as CVD risk factors and subjects without hypertension who have 3 or more other risk factors (including age) must have "Fasting LDL C of ≥120 mg/dL (3.1 mmol/L) and <160 mg/dL (4.1mmol/L)"; Subjects without hypertension who have fewer than 3 other risk factors (including age) must have "Fasting LDL-C of ≥120 mg/dL (3.1 mmol/L) and <190 mg/dL (4.9 mmol/L)"
• Triglycerides <500 mg/dL (5.65 mmol/L) at Visit 1
• HDL-C levels ≤60 mg/dL (1.6 mmol/L) at Visit 1
• Maximum IMT ≥1.2 mm and <3.5 mm at any location in the carotid ultrasound scans conducted at both Visit 2 and Visit 3
• Willing to follow all study procedures including study visits, fasting blood draws, and compliance with study treatment regimen

Exclusion criteria

• Use of pharmacologic lipid-lowering medications (eg, statins, fibrate derivatives,bile acid binding resins, niacin, or its analogues at doses >400 mg or prescribed Chinese traditional drugs), including cholesterol-absorption inhibitors (CAIs), and CAI/statin combination, within 12 months prior to Visit 1
• Current or recent (within 2 weeks of Visit 1) use of supplements known to alter lipid metabolism (eg, soluble fibers [including >2 teaspoons Metamucil® or psyllium-containing supplement per day] or other dietary fiber supplements, marine oils, sterol/stanol products, or other supplement determined at the discretion of the investigator)
• History of hypersensitivity reactions to other HMG-CoA reductase inhibitors
• Pregnant women, women who are breast-feeding, and women of childbearing potential who are not using chemical or mechanical contraception or who have a positive serum pregnancy test
• Clinical evidence of coronary artery disease (CAD) or any other atherosclerotic disease such as angina, MI, transient ischemic attack, symptomatic CAD, cerebrovascular accident, percutaneous coronary intervention, coronary artery bypass graft, peripheral arterial disease, abdominal aortic aneurysm
• History of cancer (other than basal cell carcinoma) in the past 2 years
• Uncontrolled hypertension defined as either a mean resting diastolic blood pressure of ≥110 mmHg or a resting systolic blood pressure of ≥180 mmHg recorded at any time during the screening period
• History of diabetes mellitus or current diabetes mellitus
• Uncontrolled hypothyroidism defined as a thyroid stimulating hormone (TSH) >1.5 times the upper limit of normal (ULN) at Visit 1 or subjects whose thyroid replacement therapy was initiated within the last 3 months
• History of heterozygous or homozygous familial hypercholesterolemia or known hyperlipoproteinemia Types I, III, IV, or V (familial dysbetalipoproteinemia)
• Use of the disallowed concomitant medications within 12 months prior to Visit 1
• History of alcohol and/or drug abuse within the past 5 years
• Active liver disease or hepatic dysfunction as defined by elevations of ≥1.5 x ULN at Visit 1 in any of the following liver function tests: ALT, AST or bilirubin
• Serum creatine kinase (CK) >3 x ULN at Visit 1
• Serum creatinine >2.0 mg/dL (177 mmol/L) recorded during the screening period
• Participation in another investigational drug study, and having ingested investigational drug ≤4 weeks before enrollment in the screening period
• Previous randomization in the present study
• History of a significant medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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543 participants in 2 patient groups, including a placebo group

Rosuvastatin

Experimental group

Description:

20 mg tablets, Daily oral dose

Treatment:

Drug: Rosuvastatin

Placebo

Placebo Comparator group

Description:

Matching placebo tablets

Treatment:

Drug: Placebo