UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005262 |
|---|---|
| Receipt number | R000006258 |
| Scientific Title | Candesartan-Based Treatment for Variability Lowering of Individual Blood Pressure and Heart Rate at Home Study |
| Date of disclosure of the study information | 2011/05/01 |
| Last modified on | 2024/03/25 16:23:16 |
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Basic information
Public title
Candesartan-Based Treatment for Variability Lowering of Individual Blood Pressure and Heart Rate at Home Study
Acronym
Candesartan-Based Treatment for Variability Lowering of Individual Blood Pressure and Heart Rate (CAVALIER) at Home Study
Scientific Title
Candesartan-Based Treatment for Variability Lowering of Individual Blood Pressure and Heart Rate at Home Study
Scientific Title:Acronym
Candesartan-Based Treatment for Variability Lowering of Individual Blood Pressure and Heart Rate (CAVALIER) at Home Study
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of angiotensin II receptor blocker (ARB)/calcium channel blocker (CCB) combination tablet and ARB/hydrochlorothiazide (HCTZ) combination tablet on the day-to-day variability of self blood pressure (BP) measurement at home.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Day-to-day variability (standard deviation and coefficiency of variance) of self-measured home systolic BP and heart rate after 6-month treatment
Key secondary outcomes
1. Visit-to-visit variability of casual BP and heart rate at every clinic visit
2. [morning BP]-[evening BP]
3. Achievement ratios of BP targets (casual BP, morning BP, and evening BP)
4. Changes in circulating levels of hsCRP, hsTnT, NT-proBNP, and collage III N-terminal peptide after 6-month treatment
5. Change in urine microalbumin after 6-month treatment
6. Tolerability and adverse effects
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Candesartan 8 mg/amlodipine 5mg once a day
Interventions/Control_2
Candesartan 8mg/HCTZ 6.25mg once a day
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
1. Out patients
2. Patients who can not achieve JSH2009 target levels of casual BP, morning BP, or evening BP even under treatment of antihypertensive drug(s)
Key exclusion criteria
1. Poorly controlled hypertension (DBP greater than 120mmHg)
2. Poorly controlled diabetic patients (HbA1c greater than 9.0%)
3. Gout or serum uric acid greater than 8.0mg/dL
4. Renal insufficiency (serum creatinine greater than 2.0mg/dl)
5. Hyperkalimia (K greater than 5.5 mmol/L)
6. Liver damage (gamma-GTP or ALT greater than 3 x normal upper limit)
7. Endocrine secondary hypertension
8. Malignant hypertension
9. Contraindication for candesartan, amlodipine, orHCTZ
10. Prescribed ARB/CCB tablet or ARB/HCTZ tablet before registration
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Kai |
Organization
Kurume University School of Medicine
Division name
Department of Internal Medicine Division of Cardio-Vascular Medicine
Zip code
830-0011
Address
67 Asahimachi, Kurume, Fukuoka 830-0011
TEL
+81-942-31-7562
naikai@ned.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Kai |
Organization
Kurume University School of Medicine
Division name
Department of Internal Medicine Division of Cardio-Vascular Medicine
Zip code
830-0011
Address
67 Asahimachi, Kurume, Fukuoka 830-0011
TEL
+81-942-31-7562
Homepage URL
naikai@med.kurume-u.ac.jp
Sponsor or person
Institute
Department of Internal Medicine Division of Cardio-vascular Medicine, Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine Division of Cardio-vascular Medicine, Kurume University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Kurume University IRB Center
Address
67 Asahimachi , Kurume, Japan
Tel
+81-942-35-3311
rinsyou-cen@kurume-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
10272
Org. issuing International ID_1
The Ethical Committee for the Clinical Research of Kurume University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
久留米大学病院（福岡県）、久留米大学医療センター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
928
Results
N/A
Results date posted
| 2019 | Year | 03 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
N/A
Participant flow
N/A
Adverse events
N/A
Outcome measures
N/A
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2011 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Analyzing
Management information
Registered date
| 2011 | Year | 03 | Month | 16 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006258
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