UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005126 |
|---|---|
| Receipt number | R000006094 |
| Scientific Title | Relationship between sodium balance and circadian BP rhythm in acute phase during the olmesartan treatment. |
| Date of disclosure of the study information | 2011/02/23 |
| Last modified on | 2016/10/16 11:10:54 |
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Basic information
Public title
Relationship between sodium balance and circadian BP rhythm in acute phase during the olmesartan treatment.
Acronym
Olmesartan & Na+ dynamics
Scientific Title
Relationship between sodium balance and circadian BP rhythm in acute phase during the olmesartan treatment.
Scientific Title:Acronym
Olmesartan & Na+ dynamics
Region
| Japan |
Condition
Condition
Chronic Kidney Disease (CKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to investigate which comes first, night-time BP reduction or daytime natriuresis increase during olmesartan treatment.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Temporal relationship between night-time BP reduction and daytime natriuresis increase during the first 3 days under the olmesartan treatment.
Key secondary outcomes
Glomerular filtration rate, urinary excretion rates of albumin, potassium and chloride.
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
Oral administeration of olmesartan (20 mg/day) once in the morning
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
To be eligible for the study is:
1) 6 g/day of salt intake at least 1 week before enrollment, 2)CKD patients according to K/DOQI criteria, 3) necessity of olmesartan therapy for CKD treatment, 4) documented informed consent.
Key exclusion criteria
Exclusion criteria is as follows:
1) receiving angiotensin receptor blocker, angiotensin converting enzyme inhibitor or diuretics for >2 months, 2) contraindication for the study drug, 3) presence or possibility of pregnancy, 4) HbA1c 9.0% or more, 5) GOT >100, GPT >85, 6) secondary hypertension , 7) accelerated or malignant hypertension (progressive renal dysfunction with diastolic BP of 120-130 mmHg or more), 8) serious congestive heart failure, coronary diseases, arrhythmia, or systemic diseases, 9) nephrotic syndrome with marked edema, or 10) any reason for eligibility suggested by the attending doctor.
Target sample size
20
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
Department of Cardio-Renal Medicine and Hypertension
Zip code
Address
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
Department of Cardio-Renal Medicine and Hypertension
Zip code
Address
Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8077
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
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 | 02 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Eight patients provided informed consent.
At baseline, three of the eight patients had dipper circadian BP rhythm and five had non-dipper BP rhythm. The three dippers at baseline exhibited an increase in daytime natriuresis (UNaV) within 2 days after starting ARB treatment. One of the five non-dippers showed an increase in UNaV on the first day of treatment and the rhythm was restored to a dipper pattern on the same day. The other four non-dippers at baseline had no change in this status in the first 2 days of treatment. However, all four patients had an increase in daytime UNaV within 2 days after starting treatment (1 day for three patients; 2 days for one patient), even though circadian BP rhythm was not restored. These findings indicate that the increase in daytime UNaV is not attributable to BP reduction during the previous night. Rather, the increase in daytime UNaV can restore the circadian BP rhythm. We postulate that diuretics suppress most of the FRNa at their action site, whereas ARBs suppress inappropriate enhancement of FRNa stimulated by intrarenal RAS.
(J Renin Angiotensin Aldosterone Syst. 2014 May 15)
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 | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 25 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 25 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 25 | Day |
Other
Other related information
published
Management information
Registered date
| 2011 | Year | 02 | Month | 23 | 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=R000006094
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