UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008913 |
|---|---|
| Receipt number | R000010454 |
| Scientific Title | Comparison of the effects of celiprolol and bisoprolol on central BP and measures of atherosclerosis in hypertensive patients. |
| Date of disclosure of the study information | 2012/09/13 |
| Last modified on | 2013/09/14 08:51:12 |
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Basic information
Public title
Comparison of the effects of celiprolol and bisoprolol on central BP and measures of atherosclerosis in hypertensive patients.
Acronym
Comparative study between celiprolol and bisoprolol (CB trial)
Scientific Title
Comparison of the effects of celiprolol and bisoprolol on central BP and measures of atherosclerosis in hypertensive patients.
Scientific Title:Acronym
Comparative study between celiprolol and bisoprolol (CB trial)
Region
| Japan |
Condition
Condition
Hypertensive patients.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of two different types of beta blockers, celiprolol and bisoprolol, on central BP, endotherial function, autonomic nerve functions, and glucose and lipid metabolism in hypertensive patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Effects on casual blood pressure
Extent of BP reduction (SBP, DBP, and mean BP)
2.Ambulatory BP
Extent of BP reduction (SBP, DBP, and mean BP)
3.Pulse wave velocity (PWV), pulse wave analysis (PWA), augmentation index (AI) , central BP
4.The effects on the measures of cardiac and renal target organ damage (urinary microalbumin, hsCRP, hsTroponin T, BNP, NT-proBNP)
5.Effects on glucose and lipid
6.Effects on the measures of insulin resistance (HOMA-R)
7.Effects on autonomic nervous functions (CVRR, BRS etc)
Key secondary outcomes
Adverse effects, and safety measures.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administer celiprolol 100mg from the beginning and titrated up to 200mg for a total of 12 weeks. If the clinic BP is 140/90mmHg or more at the time of 4th week, the dose will be increased from 100 to 200mg.
Interventions/Control_2
Administer bisoprolol 2.5mg from the beginning and titrated up to 5mg for a total of 12 weeks. If the clinic BP is 140/90mmHg or more at the time of 4th week, the dose will be increased from 2.5 to 5mg.
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
| 25 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.The Age>=25 years
2.Hypertensive patients
3.Patients who are not taking beta blockers
4. Secondary hypertension will be included
Key exclusion criteria
1.Patients with malignant hypertension
2.Decompensated heart failure (NYHA III or IV)
3. Malignancy needing treatment
4.Hepatic or renal disease (serum creatinine >3.0mg/dl or under hemodialysis)
5.Those who had had severe side effects with beta blockers
6.Those with contraindication for beta blockers (bronchial asthma, bradycardia, vasospastic angina, pregnant women etc.)
7.Those with hyper- or hypoglycemic attack
8. Those with dementia from whom we cannot obtain informed consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Eguchi |
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Eguchi |
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
ke112@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
International University of Health and Welfare Hospital
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 13 | 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 | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 13 | Day |
Last modified on
| 2013 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010454
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