UMIN-CTR Clinical Trial

Basic information
Public title	Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients
Acronym	CASE-J
Scientific Title	Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients
Scientific Title:Acronym	CASE-J
Region	Japan

Condition
Condition	Hypertension
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to compare an angiotensin II receptor antagonist (candesartan cilexetil– Blopress®) and a calcium channel blocker (amlodipine besilate– Norvasc®/Amlodin®) in terms of the incidence of cardiovascular events among high-risk hypertensive patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	Sudden death: death of endogenous origin within 24 hours after acute onset; Cerebrovascular events: new occurrence or recurrence of a stroke or transient ischemic attack ; Cardiac events: new occurrence, aggravation, or recurrence of heart failure, angina pectoris, or acute myocardial infarction; Renal dysfunction: serum creatinine ≥4.0 mg/dl, end stage renal disease, doubling of serum creatinine (however, creatinine ≤2.0 mg/dl is not regarded as an event); Vascular events: new occurrence or aggravation of dissecting aneurysm of aorta, arteriosclerotic occlusion of peripheral artery
Key secondary outcomes	All deaths Involution of left ventricular; hypertrophy (LVMI); Proportion of the subjects who withdrew from the allocated treatment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Candesartan cilexetil (Blopress®) administered orally at a dose of 4–8 mg/day. When necessary, the dose was increased up to 12 mg/day. However, in patients with renal impairment, the drug was started from 2 mg/day and increased up to 8 mg/ day when necessary. The targets of BP control are as follows, <60age:SBP<130 DBP<85 60s:SBP<140 DBP<90 70s:SBP<150 DBP<90 80s:SBP<160 DBP<90 Following randomization, patients will be monitored with the appropriate frequency as judged by the collaborating physicians. The dose of the assigned drug can be gradually increased up to the maximum dosage (for candesartan, 12 mg/day) to achieve the therapeutic goals. If not achieved by the maximum dosage of each drug, any antihypertensive drugs other than the angiotensin II receptor antagonist, the calcium channel blocker, or ACE inhibitors can be added.
Interventions/Control_2	Amlodipine besilate (Norvasc®/ Amlodin®) administered orally at a dose of 2.5–5 mg/day and increased up to 10 mg/day when necessary. The targets of BP control are as follows, <60age:SBP<130 DBP<85 60s:SBP<140 DBP<90 70s:SBP<150 DBP<90 80s:SBP<160 DBP<90 Following randomization, patients will be monitored with the appropriate frequency as judged by the collaborating physicians. The dose of the assigned drug can be gradually increased up to the maximum dosage (for amlodipine, 10 mg/day) to achieve the therapeutic goals. If not achieved by the maximum dosage of each drug, any antihypertensive drugs other than the angiotensin II receptor antagonist, the calcium channel blocker, or ACE inhibitors can be added.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	1.SBP >=140 mmHg in those <70 years old or >=160 mmHg in those >=70 years old or DBP >=90 mmHg in a sitting position on two consecutive measurements at clinic 2.At least one of the following risk factors: a) SBP >=180 mmHg or DBP >=110 mmHg on two consecutive visits b) Type 2 diabetes (fasting blood glucose >=126 mg/dl, causal blood glucose >=200 mg/dl, HbA1c >=6.5%, 2h blood glucose on 75gOGTT >=200 mg/dl,or current treatment with hypoglycemic agent) c) History of cerebral hemorrhage, cerebral infarction, or transient ischemic attack until 6 months prior to the screening d) Thickness of the posterior wall of left ventricle or thickness of the wall of interventricular septum >=12 mm on echocardiography or Sv1+RV5 >=35 mm on electrocardiography, angina pectoris, and a past history (>=6 months before giving informed consent) of myocardial infarction. e) Proteinuria >=+1 or renal impairment (serum creatinine >=1.3 mg/dl) within 3 months at the time of giving informed consent. f) Arteriosclerotic peripheral arterial obstruction (Fontaine class >=2)
Key exclusion criteria	1.SBP ≥200 mmHg or DBP ≥120 mmHg in a sitting position 2.Type I diabetes mellitus 3.History of myocardial infarction or cerebrovascular accidents within 6 months prior to the screening 4.PTCA or CABG done within 6 months of screening or scheduled 5.Current treatment for congestive cardiac failure (NYHA functional class II or severer) or ejection fraction <40% 6.Coronary artery disease requiring beta blocker or calcium channel blocker 7.Atrial fibrillation or atrial flutter 8.Renal dysfunction (serum creatinine ≥3 mg/dl) 9.Hepatic dysfunction (AST and/or ALT ≥100 IU/l) 10.A history of malignant tumor within 5 years of enrollment or suspected 11.Contraindication for candesartan cilexetil or amlodipine besilate 12.Pregnancy, possible pregnancy, or plan to conceive a child within 5 years of enrollment 13.Not suited to the clinical trail as judged by a collaborating physician 14.Inability to give informed consent
Target sample size	4000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takao Saruta
Organization	Keio University
Division name	School of Medicine
Zip code
Address	Sugimoto Building 2F, 1-12, Shinano-machi, Sinjyuku-ku, Tokyo
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Junichi Sakamoto
Organization	Kyoto University
Division name	Epidemiological & Clinical Research Information Management
Zip code
Address
TEL
Homepage URL
Email	sakamoto@pbh.med.kyoto-u.ac.jp

Sponsor
Institute	EBM Collaborating Research Center in Kyoto University
Institute
Department

Funding Source
Organization	The Japanese Society of Hypertension
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT00125463
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2005 Year 10 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2001 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2001 Year 09 Month 01 Day
Last follow-up date	2005 Year 12 Month 01 Day
Date of closure to data entry	2006 Year 06 Month 01 Day
Date trial data considered complete	2006 Year 08 Month 01 Day
Date analysis concluded	2006 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 10 Month 24 Day
Last modified on	2006 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000336

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
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