UMIN-CTR Clinical Trial

Public title

ARB and CCB longest combination treatment on ambulatory and home BP in hypertension with atrial fibrillation
-Multicenter study on time of dosing

Acronym

ARB and CCB longest combination treatment on ambulatory and home BP in hypertension with atrial fibrillation
-Multicenter study on time of dosing (ACROBAT)

Scientific Title

ARB and CCB longest combination treatment on ambulatory and home BP in hypertension with atrial fibrillation
-Multicenter study on time of dosing

Scientific Title:Acronym

ARB and CCB longest combination treatment on ambulatory and home BP in hypertension with atrial fibrillation
-Multicenter study on time of dosing (ACROBAT)

Region

Japan

Condition

Hypertension and atrial fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluation of 24-hour antihypertensive effect of long-acting ARB-CCB tablet administrated to hypertensive patients with atrial fibrillation, and comparison of 24-hour antihypertensive effect of long-acting ARB-CCB tablet between morning administration and bedtime administration.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Efficacy:
Change in 24-hour average blood pressure from baseline to Week 12.

Key secondary outcomes

Efficacy:
Change in the following from baseline to Week 12:
- Blood pressures at nighttime, early-morning, and daytime
- Blood pressure at hospital visit
- Blood pressure at home
- Blood pressure control rate
- Blood pressure variability
- Laboratory parameters (blood insulin, hsTnT, PAI-1, and NT-ProBNP)
Safety:
- Adverse events
- Onset of atrial fibrillation
- Pulse rate
- PWV value
- Laboratory parameters

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Participants will be treated with one telmisartan-amlodipine tablet once in the morning for 12 weeks (study treatment).

Interventions/Control_2

Participants will be treated with one telmisartan-amlodipine tablet once before retiring for 12 weeks (study treatment).

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) Hypertensive patients who meet the following conditions:
Patients who meet any of the following standards of blood pressure after administration of 40 mg/day telmisartan or 5 mg/day amlodipine for 4 weeks:
- Blood pressure at hospital visit: Systolic blood pressure is 140 mmHg or higher, or diastolic blood pressure is 90 mmHg or higher.
(average of 3 measurements obtained at a scheduled visit)
- Blood pressure at home: Systolic blood pressure is 135 mmHg or higher, or diastolic blood pressure is 85 mmHg or higher.
(average of measurements for the 5 days prior to drug assignment [4 measurements per day in total: 2 in the morning and 2 before bedtime])
2) Patients with atrial fibrillation detected on an electrocardiogram within the last 2 years prior to obtaining informed consent.
3) Age: 20 years old or older (at time of informed consent)
4) Sex: male or female
5) Clinical classification: Outpatient
6) Patients who give written consent of agreement to voluntarily participate in the clinical study.

Key exclusion criteria

1) Patients with combined serious liver and kidney disease
2) Patients with a history of allergy to telmisartan or amlodipine
3) Patients receiving antihypertensives other than telmisartan or amlodipine during observation period
4) Patients diagnosed with persistent atrial fibrillation or chronic (permanent) atrial fibrillation.
5) Patients with atrial fibrillation caused by irreversible illness (e.g., heart surgery, pulmonary embolism, or hyperthyroidism)
6) Patients with average systolic blood pressure at hospital visit higher than 180 mmHg during observation period.
7) Patients with New York Heart Association (NYHA) class III-IV heart failure, patients with heart failure requiring hospitalization, or patients with poor left ventricular function.
8) Patients who have stroke or cardiac infarction within 6 months before giving consent.
9) Patients planning to undergo pulmonary artery ablation surgery or any surgical procedure (including PCI).
10) Patients who are breast-feeding, pregnant, possibly pregnant, or plan to become pregnant.
11) In addition, patients who are determined as not eligible by their study doctor.

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Kazuomi Kario

Organization

Jichi Medical University

Division name

Department of Internal Medicine, Cardiology

Zip code

Address

3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken 329-0498, Japan

TEL

0285-58-7344

Email

kkario@jichi.ac.jp

Name of contact person

1st name
Middle name
Last name	ACROBAT Administrative office

Organization

ACROBAT Administrative office

Division name

Satt Co., Ltd. Customer Satisfaction Department

Zip code

Address

Urbanprem Shinjuku 5F, 2-12-8 Shinjuku, Shinjuku-ku, Tokyo, Japan

TEL

03-5312-5026

Homepage URL

Email

acrobat-study@sa-tt.co.jp

Institute

ACROBAT Research Group

Institute

Department

Personal name

Organization

The Waksman Foundation of Japan Inc.

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

NCT01748253

Org. issuing International ID_1

National Institutes of Health

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

61

Date of disclosure of the study information

2012

Year

10

Month

19

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

2012

Year

10

Month

15

Day

Date of IRB

Anticipated trial start date

2012

Year

11

Month

01

Day

Last follow-up date

2014

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

10

Month

17

Day

Last modified on

2014

Year

05

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010704