UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005886 |
|---|---|
| Receipt number | R000006953 |
| Scientific Title | A clinical study on the usefulness of combination tablet of candesartan and hydrochlorothiazide in hypertensive patients |
| Date of disclosure of the study information | 2011/06/30 |
| Last modified on | 2013/07/01 08:02:45 |
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Basic information
Public title
A clinical study on the usefulness of combination tablet of candesartan and hydrochlorothiazide in hypertensive patients
Acronym
A clinical study on the usefulness of combination tablet of candesartan and hydrochlorothiazide in hypertensive patients
Scientific Title
A clinical study on the usefulness of combination tablet of candesartan and hydrochlorothiazide in hypertensive patients
Scientific Title:Acronym
A clinical study on the usefulness of combination tablet of candesartan and hydrochlorothiazide in hypertensive patients
Region
| Japan |
Condition
Condition
hypertensive patients
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the combination tablet of candesartan and hydrochlorothiazide effect on urinary angiotensinogen concentration in hypertensive patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of urinary angiotensinogen and blood pressure
Key secondary outcomes
Change of serum uric acid, BNP, and urinary albumin excretion
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
combination tablet of candesartan and hydrochlorothiazide
Interventions/Control_2
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Uncontrolled hypertensive patients
BP >= 130/80mmHg
Outpatients
Key exclusion criteria
Serum creatinine > 2.5 mg/dL
Liver damage
Pregnant or possibly pregnant patients
Lactation period
Nephrotic syndrome
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iwao Ohno MD |
Organization
Jikei University School of Medicine
Division name
Division of Kidney and Hypertension, Department of Internal Medicine
Zip code
Address
3-25-8 Nishi-Shinbashi Minato-ku, Tokyo, JAPAN
TEL
03-3433-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iwao Ohno MD |
Organization
Jikei University School of Medicine
Division name
Division of Kidney and Hypertension, Department of Internal Medicine
Zip code
Address
3-25-8 Nishi-Shinbashi Minato-ku, Tokyo, JAPAN
TEL
03-3433-1111
Homepage URL
i-ohno@jikei.ac.jp
Sponsor or person
Institute
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Saiseikai Central Hospital, Renal Division
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
東京慈恵会医科大学附属病院腎臓・高血圧内科、東京都済生会中央病院腎臓内科
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 30 | 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
| 2011 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 30 | Day |
Last modified on
| 2013 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006953
