UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005601 |
|---|---|
| Receipt number | R000006618 |
| Scientific Title | Effect of the Combination of varsartan with HCTZ on circadian BP rhythm |
| Date of disclosure of the study information | 2011/05/23 |
| Last modified on | 2016/10/16 10:52:31 |
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Basic information
Public title
Effect of the Combination of varsartan with HCTZ on circadian BP rhythm
Acronym
Varsartan & HCTZ
Scientific Title
Effect of the Combination of varsartan with HCTZ on circadian BP rhythm
Scientific Title:Acronym
Varsartan & HCTZ
Region
| Japan |
Condition
Condition
Chronic Kidney Disease (CKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether or not the additional medication of diuretics to ARB can restore non-dipper circadian BP rhythm.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Decrease in the night/day ratio ofmean arterial pressure (MAP)
Key secondary outcomes
office BP, night/day ratios of natriuresis and albuminuria, urinary angiotensinogen excretion rate, plasma catecholamines
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
additional medication of HCTZ (12.5mg/d) to valsartan (80mg/d, once in the morning) for 2 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. received medical care at Nagoya City University Hospital; age of 20 or more y
2. CKD criteria based on K/DOQI
3. previous treatment with valsartan (80mg/d) for 2 months or more, office BP >130/80 on at least one occasion
4. documented informed concent
Key exclusion criteria
1. previous treatment with ARB, other than valsartan, or diuretics 2 months before enrollment
2. contraindication to valsartan or HCTZ (history of allergic reaction to them, bilateral renal artery stenosis)
3. presence or possibility of pregnancy
4. HbA1c 9.0 or more %
5. GOT >100, or GPT >85
6. endocrine hypertension
7. accelerated o r malignant hypertension (progressive renal dysfunction with diastolic BP of >120-130 mmHg
8. serious conditions with congestive heart failure, coronary diseases, arrhythmia or systemic diseases
9. nephrotic syndrome (serum albumin <2.5 g/dl)
10. patients under hemodialysis therapy
11. any reason for ineligibility suggested by the attending doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Fukuda |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Cardio-Renal Medicine and Hypertension
Zip code
Address
1 Kawasumi, Mizuho-ku, Nagoya 467-8601, Japan
TEL
81-52-853-8221
m-fukuda@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Fukuda |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Cardio-Renal Medicine and Hypertension
Zip code
Address
1 Kawasumi, Mizuho-ku, Nagoya 467-8601, Japan
TEL
81-52-853-8221
Homepage URL
m-fukuda@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
名古屋市立大学病院 Nagoya City University Hospital (愛知県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
http://www.med.nagoya-cu.ac.jp/cr.dir/
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Of the 25 eligible patients, one had excess BP reduction during add-on HCTZ therapy and another was judged as excessive urine collection, and they were excluded from the study.
Lower Na balance was produced by add-on HCTZ to ARB treatment without an increase of intrarenal renin-angiotensin system activity, leading to restoration of nocturnal hypertension.
J Renin Angiotensin Aldosterone Syst. 2016 Jun 9;17(2):1470320316652032
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 | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 15 | Day |
Last modified on
| 2016 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006618
