UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005126
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email m-fukuda@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006094

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.