UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010419 |
|---|---|
| Receipt number | R000011902 |
| Scientific Title | A Study on the Effects of Chronotherapy of Hypertension with Olmesartan on Blood-pressure Variability, Sympathetic Function, and Renal Function in Patients with Type 2 Diabetes Mellitus and Hypertension |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2017/04/06 18:36:48 |
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Basic information
Public title
A Study on the Effects of Chronotherapy of Hypertension with Olmesartan on Blood-pressure Variability, Sympathetic Function, and Renal Function in Patients with Type 2 Diabetes Mellitus and Hypertension
Acronym
J-CORRECT
Scientific Title
A Study on the Effects of Chronotherapy of Hypertension with Olmesartan on Blood-pressure Variability, Sympathetic Function, and Renal Function in Patients with Type 2 Diabetes Mellitus and Hypertension
Scientific Title:Acronym
J-CORRECT
Region
| Japan |
Condition
Condition
Patients with type 2 DM and hypertension.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this voluntary clinical study are to compare changes in home blood pressure and the effect of olmesartan on sympathetic function and renal function when administered in the morning versus before bedtime to patients with type 2 DM and hypertension.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
(i) Changes in home blood pressure from before to after administration in the morning or before bedtime (early-morning, nighttime, and before bedtime blood pressure and heart rate) and the effect of the time of administration of olmesartan on Na excretion
(ii) Effect of morning and pre-bedtime administration on blood-pressure variability (ME difference, mean ME, and day-by-day blood pressure variability)
Key secondary outcomes
(i) Changes in outpatient blood pressure and heart rate from before to after administration
(ii) Effect on the sympathetic nervous system: Changes in cortisol levels
(iii) Effect on renal function: Changes in urinary albumin and RAAS-related enzyme levels
(iv) Effect on cardiac function: Changes in BNP, NT-ProBNP, and hs-cTnT levels
(v) Effect on glucose metabolism: Changes in HbA1c and adiponectin levels
(vi) Effect on the anti-inflammatory process: Changes in hs-CRP level
(vii) Evaluation of safety such as adverse events other than the primary endpoints
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
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The morning olmesartan groups of patients with type 2 DM and hypertension
n=100
Interventions/Control_2
The pre-bedtime olmesartan groups of patients with type 2 DM and hypertension n=100
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
| 30 | years-old | < |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Age:>30 to <85 years
2)Gender: Male or female
3)Patients with type 2 DM and hypertension with outpatient blood pressure of >= 130/80 mmHg despite treatment with ARBs (candesartan, losartan, valsartan, telmisartan, irbesartan, and/or azilsartan) other than olmesartan at the usual or maximum dose for at least 12 weeks in the morning
Key exclusion criteria
Patients who meet any of the following criteria will not be included in the study:
1)Patients with secondary or malignant hypertension
2)Patients with severe heart failure (NYHA Class III or higher)
3)Patients with nephrotic syndrome (or serum creatinine [Cr] >= 3.0 mg/dL)
4)Patients with serious liver or biliary diseases
5)Patients with a history of cardiovascular (myocardial infarction) or cerebral events (cerebral infarction)
6)Patients with endocrine disease
7)Patients with any malignancy
8)Patients determined by the investigator to be not suitable for other reasons
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuomi Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan.
TEL
0285-58-7344
kkario@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro Yano |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan.
TEL
0285-58-7344
Homepage URL
yyano@jichi.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
This study was supported by a grant from Jichi Medical University
School of Medicine.
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
自治医科大学附属病院（栃木県）、たまきクリニック（宮崎県）、えとう循環器科・内科クリニック（宮崎県）、横田内科（宮崎県）、 串間市民病院（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 04 | Day |
Last modified on
| 2017 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011902
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| Registered date | File name |
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| Registered date | File name |
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