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Affirmation of Primary prevention with Pravastatin in Reduction of Occlusive Atherosclerotic Complications in Hypercholesterolemia -Japan study

Affirmation of Primary prevention with Pravastatin in Reduction of Occlusive Atherosclerotic Complications in Hypercholesterolemia -Japan study

Status
Unknown
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1080220524
Enrollment
5000
Registered
2008-02-27
Start date
2008-02-27
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

investigational material(s) Generic name etc : Mevalotin (Pravastatin Sodium) INN of investigational material : Therapeutic category code : 218 Agents for hyperlipidemias Dosage and Administration fo

Sponsors

DAIICHI SANKYO COMPANY, LIMITED
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Hypercholesterolemia, under a Mevalotin treatment, outpatient, consenting patient, 2-years follow-up available, men aging >= 20, women aging >= 55 or after menopause, defined as a high risk group on primary prevention by JAS guideline 2007.

Exclusion criteria

Exclusion criteria: A history of cardiovascular diseases (myocardial infarction, unstable angina, stroke (excluding TIA), CABG/PCI, arteriosclerosis obliterans) before registration. A diagnosis severe arrhythmia, familial hypercholesterolemia, uncontrolled hypertension or diabetes mellitus, severe liver or renal disease, current diagnosis of severe disease (ex. malignancy), contraindicated to pravastatin.

Design outcomes

Primary

MeasureTime frame
Development of cardiovascular events (myocardial infarction, unstable angina required hospitalization, CABG/PCI, stroke (excluding TIA), arteriosclerosis obliterans, and sudden and unexpected death related cardiovascular disease.

Outcome results

None listed

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