UMIN-CTR Clinical Trial

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

Essential hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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.)

Study type

Interventional

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

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

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

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

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

Institute

Kazuomi Kario

Institute

Department

Personal name

Organization

Bayer Yakuhin, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Sogo Rinsho M&eacute;d&eacute;fi Co., Ltd

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

自治医科大学附属病院（栃木県）

Date of disclosure of the study information

2013

Year

08

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2013

Year

07

Month

10

Day

Last modified on

2016

Year

02

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012921