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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005262
Receipt No. 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 2020/03/22

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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
Email 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
Email naikai@med.kurume-u.ac.jp

Sponsor
Institute Department of Internal Medicine Division of Cardio-vascular Medicine, Kurume University School of Medicine
Institute
Department

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
Email 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
2021 Year 12 Month 31 Day

Other
Other related information Analyzing

Management information
Registered date
2011 Year 03 Month 16 Day
Last modified on
2020 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006258

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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