UMIN-CTR Clinical Trial

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

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

J-HOME-CARD Study group

Institute

Department

Personal name

Organization

Miyagi Kidney foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

03

Month

19

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2010

Year

03

Month

19

Day

Last modified on

2017

Year

04

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004004