UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011197 |
|---|---|
| Receipt number | R000013120 |
| Scientific Title | The hypertensive patients is RECOMMENDed for organ protection by ARB decreased early-morning blood pressure study |
| Date of disclosure of the study information | 2013/07/17 |
| Last modified on | 2015/08/24 20:12:11 |
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Basic information
Public title
The hypertensive patients is RECOMMENDed for organ protection by ARB decreased early-morning blood pressure study
Acronym
The hypertensive patients is RECOMMENDed for organ protection by ARB decreased early-morning blood pressure study (RECOMMEND study)
Scientific Title
The hypertensive patients is RECOMMENDed for organ protection by ARB decreased early-morning blood pressure study
Scientific Title:Acronym
The hypertensive patients is RECOMMENDed for organ protection by ARB decreased early-morning blood pressure study (RECOMMEND study)
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Olmesartan medoxomil is the well-known strongest angiotensin receptor blocker (ARB), which ameliorates circadian rhythm of blood pressure (BP) most preferably. Recently, azilsartan, which is proposed to be strangest ARB, became to be available. However, it is unclear which of the ARBs have a greater effect to decrease early morning BP. Thus, to clarify the question, the present study was planned.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of early morning BP with the treatment of olmesartan medoxomil or azilsartan, for 12 to 14 weeks.
Key secondary outcomes
(1) Absolute value of early morning BP after 12-14 weeks treatments. Percentage of patients with early morning BP reduction (systolic BP>20mmHg, diastolic BP>10mmHg, or mean BP>23mmHg) with 12-14 weeks treatments.
Influence of 12-14 weeks treatments on the below parameters:
(2) Standard deviation of early morning BP.
(3) Twenty-four hours ambulatory BP measurent (if possible)
(4) Office BP
(5) Serum Na, K, and urine Na, K, creatinine (Cr)
(6) Serum Cr, estimated glomerular filtration rate (eGFR). And staging of chronic kidney disease (CKD) with eGFR.
(7) Serum uric acid
(8) Urine protein/Cr ratio and staging of urine protein/Cr ratio.
(9) Adverse events and severe adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Twenty mg/day of olmesartan medoxomil is given instead of pre-administered ARB. Duration of the treatment is 12-14 weeks. Olmesartan medoxomil can be arranged up to maximum dose (40mg/day) until office BP is decreased to lower than 140/90 mmHg.
Interventions/Control_2
Twenty mg/day of azilsartan is given instead of pre-administered ARB. Duration of the treatment is 12-14 weeks. Azilsartan can be arranged up to maximum dose (40mg/day) until office BP is decreased to lower than 140/90 mmHg.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Essential hypertensive patients with early morning BP>135/85 mmHg or office BP>140/90 mmHg, who visit outpatient clinic.
* Early morning BP is average of all self-measured BP values at early morning (3-5 times/day for 5 continuous days before outpatient visit)
(2) Standard dose of ARB other than olmesartan medoxomil and azilsartan for more than 8 weeks before registration.
(3) Age is 20 years-old or more and lower than 85 years-old.
(4) Patients who can do self-measurement of BP more than 3 times/chance at early morning..
(5) Written informed content is obtained after the explanation of the study is done orally and with written document.
Key exclusion criteria
(1) Office systolic BP>180 mmHg or diastolic BP>110mmHg..
(2) Administration of angiotensin converting enzyme (ACE) inhibitor, renin inhibitor, aldosteorone antagonist, diuretic (thiazide, loop, and so on) within 3 months.
(3) Decrease in left ventricular function (left ventricular ejection rate<30%)
(4) Coexisting atrial fibrillation.
(5) Necessity of percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting.
(6) Coexisting congenital heart disease.
(7) Symptomatic heart failure, acute myocardial infarction, unstable angina, PTCA, and coronary artery bypass grafting 6 months before the start of the present trial.
(8) Percutaneous transluminal angioplasty or bypass grafting of peripheral artery 6 months before the present trial.
(9) Cerebrovascular disease 6 months before the present trial.
(10) Serum Cr>1.5 mg/dL.
(11) Coexisting liver injury (AST or ALT>100 IU/L).
(12) Coexisting fundus bleeding or papilledema with hypertensive retinopathy.
(13) Uncontrollable diabetes mellitus (hemoglobin A1c>8.0%).
(14) Hyperpotassemia (serum K>5.5 mEq/L).
(15) Pregnancy or possibility of pregnancy.
(16) Severe adverse events due to ARB.
(17) Participation of the other clinical trial within 6 months before the present trial.
(18) Ineligible patients for the present trial according to the judgment by primary physician.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ando, Katsuayuki |
Organization
University of Tokyo School of Medicine
Division name
Division of Molecular Cardiovascular Metabolism
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 112, Japan
TEL
+81-3-5800-9119
katsua-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ando, Katsuayuki |
Organization
University of Tokyo School of Medicine
Division name
Division of Molecular Cardiovascular Metabolism
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 112, Japan
TEL
+81-3-5800-9119
Homepage URL
katsua-tky@umin.ac.jp
Sponsor or person
Institute
Division of Molecular Cardiovascular Metabolism, University of Tokyo School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Molecular Cardiovascular Metabolism, University of Tokyo School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Daiichi-Sankyo Co. Ltd.
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 17 | 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
Hypertensive patients were received 23.5+/-7.6 mg/day of olmesartan medoxomil (n=53) or 24.3+/-8.3 mg/day of azilsartan (n=61). The depressor effects between olmesartan medoxomil and azilsartan were not different; The office BP was decreased similarly (from 146.4+/-11.6/81.0+/-10.5, 147.6+/-12.1/81.9+/-11.3 mmHg to 139.6+/-14.7/79.1+/-10.1, 140.4+/-12.6/78.7+/-10.5 mmHg) and morning home BP was not significantly changed (from 135.4+/-12.1/77.7+/-10.4, 139.5+/-13.3/80.6+/-10.1 to 135.6+/-14.1/77.7+/-10.2, 137.3+/-11.9/79.5+/-9.4 mmHg). SD of morning diastolic and mean BP tended to decrease with olmesartan medoxomil but not with azilsartan, and these decreases were marginally or significantly greater in olmesartan medoxomil arm. The changes on serum Na, uric acid, and Cr, eGFR, and urinary protein/Cr ratio were almost similar. However, azilsartan significantly increased serum K but olmesartan medoxomil did not. Antihypertensive potency was not different between olmesartan medoxomil and azilsartan. Although there may be slight difference in the effects between the two ARBs, the further studies are required to clarify their clinical implications.
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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 07 | Day |
Date analysis concluded
| 2014 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 16 | Day |
Last modified on
| 2015 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013120
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