Prospective, randomized, open-label, clinical trial comparing standard and intensive LDL-lowering therapies using rosuvastatin on endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties

Prospective, randomized, open-label, clinical trial comparing standard and intensive LDL-lowering therapies using rosuvastatin on endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties - Prospective, randomized, open-label, clinical trial comparing standard and intensive LDL-lowering therapies with rosuvastatin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002673

Enrollment

Registered

2010-10-28

Start date

2009-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Interventions

Lowering LDL-cholesterol with rosuvastatin to minus 30%-levels which are recommended by Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases Lowering LDL-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Hypercholesterolemic patients recommended for administration of lipid-lowering agents in Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2) Outpatients 3) Subjects who gave written informed consent

Exclusion criteria

Exclusion criteria: 1) Allergy against rosuvastatin 2) Poor-controlled hypertension (DBP>110 mmHg) 3) Poor-controlled diabetes (HbA1c>10.0 %) 4) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 5) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits. 6) Chronic renal failure (serum creatinine>2.0 mg/dl) 7) Malignancies or other diseases with poor prognosis 8) Pregnant 9) Subjects whose doctor in charge do not agree to join the trial

Design outcomes

Primary

Measure	Time frame
Serum lipids (total/LDL/HDL-cholesterol, triglycerides), 6 months after randomization Flow-mediated vasodilation in forearm, 6 months after randomization Heparin-releasable EC-SOD levels, 6 months after randomization	—

Secondary

Measure	Time frame
Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria), 6 months after randomization	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026