UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005252 |
|---|---|
| Receipt number | R000006248 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2011/03/23 |
| Last modified on | 2016/04/15 13:54:10 |
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Basic information
Public title
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
Acronym
J-CHANCE
Scientific Title
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
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Kazunori Shimada |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo 113-8421 Japan
TEL
03-3813-3111
shimakaz@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunoir Shimada |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo 113-8421 Japan
TEL
03-3813-3111
Homepage URL
shimakaz@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine, Department of Cardiovascular Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2009 | Year | 08 | Month | 30 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006248
