NIPH Clinical Trials Search

UMIN ID: UMIN000000571

Registered date:29/11/2007

A randomized control study to see the effect of intensive treatment of hypertension and hyperlipidemia on patients having documented coronary artery disease.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPatients diagnosed as having 75% or higher stenosis according to the AHA classification in at least one branch of the coronary artery with hypertension and hyperlipidemia.
Date of first enrollment2006/11/01
Target sample size500
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Intensive Therapy Therapeutic Target BP <120/80mmHg LDL-C <80mg/dL Conventional Therapy Therapeutic Target BP <140/90mmHg LDL-C <100mg/dL


Primary OutcomeComposite endpoint - all deaths, nonfatal MI/stroke/vascular/peripheral vessel events, unstable angina pectoris, all hospitalization and CABG Evaluated three years after intervention started.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum79years-old
GenderMale and Female
Include criteria
Exclude criteriaPatients are excluded from study inclusion if they have 1) allergy to test drugs 2) familial hypercholesterolemia 3) uncontrolled hyperlipidemia (LDL-C >= 180mg/dL) 4) uncontrolled hypertension (systolic blood pressure >= 180mmHg and/or diastolic blood pressure >= 110mmHg) 5) AMI and/or stroke within 3months before intervention 6) secondary hypertension 7) secondary hyperlipidemia 8) severe valvular disease including mitral stenosis or incompetence of the aortic valve 9) severe arrhythmia including ventricular fibrillation or ventricular tachyrhythmia 10) renal failure (serum creatinine >=2.5 mg/dL) 11) liver dysfunction (AST and/or ALT over three times the normal value) 12) pregnancy and/or possibility of pregnancy or if the attending doctor disqaulifies the patients to be included in the study for whatever reason.

Related Information


public contact
Name Tsutomu Yamazaki
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo Japan
Telephone 03-5800-9844
Affiliation Tokyo University Graduate School of Medicine Department of Clinical Epidemiology and Systems
scientific contact
Name Ryozo Nagai
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo Japan
Telephone 03-5800-6526
Affiliation Tokyo University Graduate School of Medicine Department of Cardiovascular Medicine