UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Japan Home vs. Office blood pressure Measurement Evaluation with CAndesartan and Restricted dose of Diuretic <J-HOME-CARD>
Title of the study (Brief title)	J-HOME-CARD Study
Region	Japan

Condition
Condition	Hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	- To compare the efficacy on home blood pressure and the safety between ECARD HD (Candesartan 8 mg/HCTZ 6.25 mg) and candesartan 8mg in patients with essential hypertension uncontrolled under monotherapy with candesartan 8mg. - To compare the effects on night-time blood pressure by using HEM-7080IC (OMRON Healthcare).
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	Difference of home morning systolic blood pressure reduction between two groups during eight-week treatment.
Key secondary outcomes	1) Differences of home blood pressure reduction and differences of proportion achievement for target blood pressure level between two groups during eight-week treatment. 2) Differences of reduction in home nocturnal blood pressure during sleep between two groups during eight-week treatment. 3) Differences of clinic blood pressure reduction and differences of proportion achievement for target blood pressure level between two groups during eight-week treatment. 4) Differences of change in eGFR between two groups during eight-week treatment. 5) Differences of change in central blood pressure and augmentation index between two groups during eight-week treatment. 6) Changes in laboratory test results including LDL-C, K, sCr, uric acid, blood sugar, and HbA1c.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	- Titration to Candesartan 12mg - Once daily - Treatment period: 8 weeks
Interventions/Control_2	- Change to Combination Tablets of candesartan 8mg / HCTZ 6.25mg - Once daily - Treatment period: 8 weeks
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	The inclusion criteria for study patients: 1) Out-patient with essential hypertension, who has not been treated or treated with monotherapy. 2) Between 20 and 80 years of age 3) Patient understands study procedures and agrees to participate in the study by giving written informed consent prior to the study. 4) Patients with average home mornig systolic blood pressure >= 135mmHg after receving monotherapy with candesartan 8mg for four week or more.
Key exclusion criteria	Exclusion criteria 1) Secondary hypertension 2) Cardiac failure (above NYHA grade III) 3) Past history of major cardiac events or intervention (e.g., myocardial infarction, stroke) within 6 months prior to the start of the study. 4) Pregnancy (positive urine pregnancy test at pre-study) or breast feeding, or a female expecting to conceive within the study. 5) Critical liver damage 6) History of severe hepatic or renal disease (sCr>2.0 mg/dl) 7) Uncontrollable arrhythmia (atrial fibrillation, etc) 8) Hypersensitivity to ARB 9) Hypersensitivity to components of thiazide or similar compounds 10)Patient ineligible to this study due to other medical reasons
Target sample size	200

Research contact person
Name of lead principal investigator	Yutaka Imai
Organization	Tohoku University Graduate School
Division name	Department of Clinical Pharmacology and Therapeutics
Address	6-3 Aoba, Aramaki, Aoba-ku, Sendai 980-8578, JAPAN
TEL	022-795-6843
Email

Public contact
Name of contact person
Organization	Tohoku University Graduate School
Division name	Department of Planning for Drug Development and Clinical Evaluation
Address	6-3 Aoba, Aramaki, Aoba-ku, Sendai 980-8578, JAPAN
TEL	022-795-6843
Homepage URL
Email

Sponsor
Institute	J-HOME-CARD Study group
Institute
Department

Funding Source
Organization	Miyagi Kidney foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2010 Year 03 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 03 Month 01 Day
Anticipated trial start date	2010 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/26041602
Results
Other related information

Management information
Registered date	2010 Year 03 Month 19 Day
Last modified on	2017 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004004