UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003356
Receipt No. R000004004
Scientific Title The Japan Home vs. Office blood pressure Measurement Evaluation with CAndesartan and Restricted dose of Diuretic <J-HOME-CARD>
Date of disclosure of the study information 2010/03/19
Last modified on 2017/04/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The Japan Home vs. Office blood pressure Measurement Evaluation with CAndesartan and Restricted dose of Diuretic <J-HOME-CARD>
Acronym J-HOME-CARD Study
Scientific Title The Japan Home vs. Office blood pressure Measurement Evaluation with CAndesartan and Restricted dose of Diuretic <J-HOME-CARD>
Scientific Title:Acronym 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
1st name
Middle name
Last name Yutaka Imai
Organization Tohoku University Graduate School
Division name Department of Clinical Pharmacology and Therapeutics
Zip code
Address 6-3 Aoba, Aramaki, Aoba-ku, Sendai 980-8578, JAPAN
TEL 022-795-6843
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tohoku University Graduate School
Division name Department of Planning for Drug Development and Clinical Evaluation
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/26041602
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
2010 Year 03 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000004004

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.