UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006904 |
|---|---|
| Receipt number | R000008134 |
| Scientific Title | Effect of olmesartan compared with candesartan on home blood pressure and prognostic makers of subsequent cardiovascular events in patients with essential hypertension: a single center, prospective, randomized, and open-labeled trial |
| Date of disclosure of the study information | 2011/12/21 |
| Last modified on | 2023/12/28 09:45:22 |
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Basic information
Public title
Effect of olmesartan compared with candesartan on home blood pressure and prognostic makers of subsequent cardiovascular events in patients with essential hypertension: a single center, prospective, randomized, and open-labeled trial
Acronym
Effect of olmesartan on home blood pressure and prognostic makers of cardiovascular events in patients with essential hypertension: a single center randomized trial
Scientific Title
Effect of olmesartan compared with candesartan on home blood pressure and prognostic makers of subsequent cardiovascular events in patients with essential hypertension: a single center, prospective, randomized, and open-labeled trial
Scientific Title:Acronym
Effect of olmesartan on home blood pressure and prognostic makers of cardiovascular events in patients with essential hypertension: a single center randomized trial
Region
| Japan |
Condition
Condition
Essential hypertension
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether treatment with olmesartan is more effective than candesartan on reducing home blood pressure and the makers of cardiovascular events in patients with essential hypertension
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
home blood pressure in early morning, left ventricular mass index on echocardiography, serum cystatin C level
Key secondary outcomes
plasma BNP level, urinary potassium, urinary micro albumin, arterial stiffness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Olmesartan treatment group; After the randomization, candesartan (4mg or 8mg/day) is switched to the treatment with olmesartan (10mg or 20mg/day) for 12 months
Interventions/Control_2
Candesartan treatment group; After the randomization, candesartan (4mg or 8mg/day) treatment will be continued for 12 months
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
| 35 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Stable hypertension patients treated with candesartan for more than one year
Key exclusion criteria
1. Atrial fibrillation or atrial flutter
2. History of congestive heart failure (NYHA functional class II or severer) within 6 months of enrollment
3. History of myocardial infarction, unstable angina, PTCA or CABG within 6 months of enrollment
4. History of PTA or lower extremities bypass surgery within 6 months of enrollment
5. History of cerebrovascular diseases within 6 months of enrollment
6. Plan to be performed PTCA or CABG
7. Congenital heart disease
8. sBP >=180 mmHg or dBP >=110 mmHg in a sitting position
9. Left ventricular ejection fraction <30%
10. Pregnancy or possible pregnancy
11. Hepatic dysfunction (AST and/or ALT >100 IU/l)
12. Renal dysfunction (serum creatinine >= 1.5 mg/dl)
13. Uncontrolled type 2 diabetes (HbA1c >= 8.0%)
14. Hypertensive retinopathy with hemorrhage, oozing or papilledema
15. Hyper potassium (serum potassium >= 5.5 mEq/L)
16. History of severe side effect of ARB
17. Current or history of participation (within 6 months of enrollment) in another clinical trial
18. Patients who are otherwise judged inappropriate for inclusion by the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyasu Minami |
Organization
The University of Tokyo Graduate School of Medicine
Division name
KAATSU Training - Ischemic Circulatory Physiology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9176
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Misako Ito |
Organization
Chiba Kensei Hospital
Division name
Clinical Research Center
Zip code
Address
TEL
043-239-2212
Homepage URL
Sponsor or person
Institute
Chiba Kensei Hospital
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
千葉県勤労者医療協会 千葉健生病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 21 | 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
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2011 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 19 | Day |
Last modified on
| 2023 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008134
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| Registered date | File name |
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