UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Candesartan/Hydrochlorothiazide Versus High-dose Candesartan for the Clinical Assessment of N-terminal pro-B Type Natriuretic Peptide Levels and Cardio-renal Protective Effects: A comparative study
Title of the study (Brief title)	J-CHANCE
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effects of high-dose candesartan and candesartan/hydrochlorothiazide on blood pressure and cardio-renal protection in hypertensive patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. The achievement rate of blood pressure targets measured at home (home BP) and at the outpatient department according to the Japanese Society of Hypertension (JSH) 2009 criteria 2. Changes in the levels of cardio-renal associated markers, inflammatory markers and glucose metabolism
Key secondary outcomes	Changes in 24-h ambulatory blood pressure, lipids, microalbuminuria, uric acid, and serum potassium

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	candesartan12mg
Interventions/Control_2	candesartan 8mg + hydrochroltiazide 6.25mg
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Age=>20 years 2. Hypertensive patients who did not achieve the target blood pressure of JHS 2009 criteria 3. Hypertensive patients treated with 8 mg/day of candesartan for more than 2 months
Key exclusion criteria	1. Patients with a history of hypersensitivity to the study drugs 2. Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics 3. Patients with chronic renal failure (serum creatinine => 2.0 mg/dL) 4. Patients with anuria or on dialysis 5. Patients with acute renal failure 6. Patients whose levels of sodium and/or potassium are obviously low 7. Patients who are pregnant, possibly pregnant, or lactating
Target sample size	100

Research contact person
Name of lead principal investigator	Kazunori Shimada
Organization	Juntendo University School of Medicine
Division name	Department of Cardiovascular Medicine
Address	2-1-1 Hongo Bunkyo-ku, Tokyo 113-8421 Japan
TEL	03-3813-3111
Email	shimakaz@juntendo.ac.jp

Public contact
Name of contact person	Kazunoir Shimada
Organization	Juntendo University School of Medicine
Division name	Department of Cardiovascular Medicine
Address	2-1-1 Hongo Bunkyo-ku, Tokyo 113-8421 Japan
TEL	03-3813-3111
Homepage URL
Email	shimakaz@juntendo.ac.jp

Sponsor
Institute	Juntendo University School of Medicine, Department of Cardiovascular Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Juntendo University School of Medicine, Department of Cardiovascular Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Juntendo University Shizuoka Hospital Juntendo University Urayasu Hospital Juntendo University Nerima Hospital Koto Hospital Tobu Chiiki Hospital Koshigaya Municipal Hospital
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	2011 Year 03 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 08 Month 30 Day
Anticipated trial start date	2009 Year 09 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 03 Month 15 Day
Last modified on	2016 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006248