臨床研究等提出・公開システム

Date of registration	Feb. 27, 2008
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080220524

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

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO COMPANY, LIMITED
	Address	http://www.daiichisankyo.co.jp/contact/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		5000
Study Type		Observational
Study Design	Study Design	Single Group Cohort
Study Design	Objective
Phase		N/A
Key inclusion & exclusion 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	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.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Hypercholesterolemia
Intervention(s)		investigational material(s) Generic name etc : Mevalotin (Pravastatin Sodium) INN of investigational material : Therapeutic category code : 218 Agents for hyperlipidemias Dosage and Administration for Investigational material : Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		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.
Secondary Outcome

Primary Sponsor	DAIICHI SANKYO COMPANY, LIMITED
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name	None
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-080534
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
10	Dec. 17, 2018	(this page)	Changes
9	April. 10, 2013	Detail	Changes
8	Jan. 10, 2012	Detail	Changes
7	Jan. 10, 2012	Detail	Changes
6	Mar. 29, 2011	Detail	Changes
5	Mar. 29, 2011	Detail	Changes
4	June. 02, 2010	Detail	Changes
3	June. 02, 2010	Detail	Changes
2	Feb. 27, 2008	Detail	Changes
1	Feb. 27, 2008	Detail

List of change history