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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011161
Receipt No. R000012921
Scientific Title High dose calcium channel blocker study for essential hypertension
Date of disclosure of the study information 2013/08/02
Last modified on 2016/02/15

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Basic information
Public title High dose calcium channel blocker study for essential hypertension
Acronym CARILLON study
Scientific Title High dose calcium channel blocker study for essential hypertension
Scientific Title:Acronym CARILLON study
Region
Japan

Condition
Condition Essential hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the efficacy and safety of high dose (80 mg/day) Nifedipine controlled-release preparation versus high dose (10mg/day) Amlodipine in patients with essential hypertension.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 24-hour mean value of blood pressure (ABPM)
Key secondary outcomes (1)Efficacy:
1. Daytime blood pressure (ABPM)
2. Nocturnal blood pressure (ABPM)
3. Morning blood pressure (ABPM)
4. Achievement ratio to targeted value of blood pressure (set the targeted value as 24-hour mean blood pressure < 130mmHg)
5. Heart rate
6. Home blood pressure
7. Home heart rate
8. NTproBNP
9. High-sensitivity troponin T
10. Blood pressure variation index (ARV, CV, SD, Peak-Trough et al.
11. Urinary albumin excretion (adjust spot urine with creatinine)
(2)Safeties:
Incidence of adverse events (headache, palpitation, edema et al.)

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 YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Nifedipine + candesartan
Once daily after breakfast during 40mg administration period.
Twice daily, after breakfast and before retiring, 40mg each during 80mg administration period.
Interventions/Control_2 Amlodipine + candesartan
Once daily after breakfast during both 5mg and 10mg administration periods.
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)Patients with refractory hypertension who have taken 3 or more kinds of antihypertensive agents for more than a month (no matter the each dosage), or who have taken 2 agents of ARB and CCB in maximum dose of normal dose for more than a month.
(2)Patients with office blood pressure (mean value of blood pressure measured twice in the same day) more than SBP 140mmHg within a month before registration, or who with home blood pressure more than SBP 140mmHg within a month before registration.
(3)20 years old or older (at the time of the informed consent) male and female
(4)Able to give written informed consent before participating in the research
Key exclusion criteria (1)Secondary hypertension
(2)Patients with history of myocardial infarction or cerebral stroke within 6 months
(3)Patients with cardiogenic shock
(4)Patients with auricular fibrillation
(5)Patients with severe liver disorders or kidney disorders
(6)Dialysis patients
(7)Pregnant, possible to pregnancy, or lactating women
(8)Patients with history of sensitivity to the ingredients
(9)Any those the investigator or other researchers consider as unsuitable
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuomi Kario
Organization Jichi Medical University
Division name The interior of Department of Internal Medicine Cardiology Section
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7344
Email kkario@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuaki Tanuma
Organization Sogo Rinsho Medefi Co., Ltd
Division name Business Promotion Department
Zip code
Address 3-2-7 Nishi-shinjuku, Shinjuku-ku, Tokyo
TEL 03-6901-6079
Homepage URL
Email carillon@sogo-medefi.jp

Sponsor
Institute Kazuomi Kario
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Sogo Rinsho M&eacute;d&eacute;fi Co., Ltd
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 自治医科大学附属病院(栃木県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 02 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
2013 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 02 Day
Last follow-up date
2015 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information According to the report of Fang et al, they suggested that there is a margin of blood pressure ( >5+/-10 mmHg ) between the group of amlodipine and nifedipine. This finding was more than expected at initiation of CARILLON study.

As a result of consideration to ethics and safety, CARILLON study should be aborted without prolonging registration period.

Management information
Registered date
2013 Year 07 Month 10 Day
Last modified on
2016 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012921

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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