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ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing (ACROBAT) (ACROBAT)

Primary Purpose

Hypertension and Atrial Fibrillation

Status

Unknown status

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Telmisartan-amlodipine tablet administration group (morning)

Telmisartan-amlodipine tablet administration group (bedtime)

About this trial

This is an interventional treatment trial for Hypertension and Atrial Fibrillation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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, and/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, and/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])
Patients with atrial fibrillation detected on an electrocardiogram within the last 2 years prior to obtaining informed consent.
Age: 20 years old or older (at time of informed consent)
Sex: male or female
Clinical classification: Outpatient
Patients who give written consent of agreement to voluntarily participate in the clinical study.

Exclusion Criteria:

Patients with serious liver and/or kidney disease
Patients with history of allergy to telmisartan or amlodipine
Patients receiving antihypertensives other than telmisartan or amlodipine during observation period
Patients diagnosed with persistent atrial fibrillation or chronic (permanent) atrial fibrillation.
Patients with atrial fibrillation caused by irreversible illness (e.g., heart surgery, pulmonary embolism, or hyperthyroidism)
Patients with average systolic blood pressure at hospital visit higher than 180 mmHg during observation period.
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.
Patients who have stroke or cardiac infarction within 6 months before giving consent.
Patients planning to undergo pulmonary artery ablation surgery or any surgical procedure (including PCI).
Patients who are breast-feeding, pregnant, possibly pregnant, or plan to become pregnant.
In addition, patients who are determined as not eligible by their study doctor.

Sites / Locations

Uchiyama ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Telmisartan-amlodipine tablet administration group (morning)

Telmisartan-amlodipine tablet administration group (bedtime)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in blood pressures at night time, early-morning, and daytime from baseline to Week 12.

Change in blood pressure at hospital visit from baseline to Week 12.

Change in blood pressure at home from baseline to Week 12.

Change in blood pressure control rate from baseline to Week 12.

Change in blood pressure variability from baseline to Week 12.

Change in laboratory parameters (blood insulin, hsTnT, PAI-1, and NT-ProBNP) from baseline to Week 12.

Onset of Adverse events

Onset of atrial fibrillation

Pulse rate

PWV value

Clinical laboratory test results

Full Information

NCT ID

NCT01748253

First Posted

November 16, 2012

Last Updated

May 20, 2013

Sponsor

Acrobat Trial Group

1. Study Identification

Unique Protocol Identification Number

NCT01748253

Brief Title

ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing (ACROBAT)

Acronym

ACROBAT

Official Title

ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Unknown status

Study Start Date

November 2012 (undefined)

Primary Completion Date

October 2013 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Acrobat Trial Group

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension and Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Telmisartan-amlodipine tablet administration group (morning)

Arm Type

Active Comparator

Arm Title

Telmisartan-amlodipine tablet administration group (bedtime)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Telmisartan-amlodipine tablet administration group (morning)

Intervention Description

Oral-administration of one telmisartan-amlodipine tablet once a day upon morning for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Telmisartan-amlodipine tablet administration group (bedtime)

Intervention Description

Oral-administration of one telmisartan-amlodipine tablet once a day at bedtime for 12 weeks

Primary Outcome Measure Information:

Title

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

Time Frame

Baseline and 12 weeks.

Secondary Outcome Measure Information:

Title

Change in blood pressures at night time, early-morning, and daytime from baseline to Week 12.

Time Frame

Baseline and 12 weeks.

Title

Change in blood pressure at hospital visit from baseline to Week 12.

Time Frame

Baseline and 12 weeks.

Title

Change in blood pressure at home from baseline to Week 12.

Time Frame

Baseline and 12 weeks.

Title

Change in blood pressure control rate from baseline to Week 12.

Time Frame

Baseline and 12 weeks.

Title

Change in blood pressure variability from baseline to Week 12.

Time Frame

Baseline and 12 weeks.

Title

Change in laboratory parameters (blood insulin, hsTnT, PAI-1, and NT-ProBNP) from baseline to Week 12.

Time Frame

Baseline and 12 weeks.

Title

Onset of Adverse events

Time Frame

Baseline and 12 weeks.

Title

Onset of atrial fibrillation

Time Frame

Baseline and 12 weeks.

Title

Pulse rate

Time Frame

Baseline and 12 weeks.

Title

PWV value

Time Frame

Baseline and 12 weeks.

Title

Clinical laboratory test results

Time Frame

Baseline and 12 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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, and/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, and/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]) Patients with atrial fibrillation detected on an electrocardiogram within the last 2 years prior to obtaining informed consent. Age: 20 years old or older (at time of informed consent) Sex: male or female Clinical classification: Outpatient Patients who give written consent of agreement to voluntarily participate in the clinical study. Exclusion Criteria: Patients with serious liver and/or kidney disease Patients with history of allergy to telmisartan or amlodipine Patients receiving antihypertensives other than telmisartan or amlodipine during observation period Patients diagnosed with persistent atrial fibrillation or chronic (permanent) atrial fibrillation. Patients with atrial fibrillation caused by irreversible illness (e.g., heart surgery, pulmonary embolism, or hyperthyroidism) Patients with average systolic blood pressure at hospital visit higher than 180 mmHg during observation period. 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. Patients who have stroke or cardiac infarction within 6 months before giving consent. Patients planning to undergo pulmonary artery ablation surgery or any surgical procedure (including PCI). Patients who are breast-feeding, pregnant, possibly pregnant, or plan to become pregnant. In addition, patients who are determined as not eligible by their study doctor.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shinji Mitoma

Phone

+81-3-5312-5026

acrobat-study@sa-tt.co.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kazuomi Kario

Organizational Affiliation

Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Uchiyama Clinic

City

Joetsu city

State/Province

Niigata pref.

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kazuaki Uchiyama

Phone

+81-25-548-2400

12. IPD Sharing Statement

Citations:

PubMed Identifier

26989846

Citation

Kario K, Hoshide S, Uchiyama K, Yoshida T, Okazaki O, Noshiro T, Aoki H, Mizuno H, Matsumoto Y. Dose Timing of an Angiotensin II Receptor Blocker/Calcium Channel Blocker Combination in Hypertensive Patients With Paroxysmal Atrial Fibrillation. J Clin Hypertens (Greenwich). 2016 Oct;18(10):1036-1044. doi: 10.1111/jch.12814. Epub 2016 Mar 16.

Results Reference

derived

Learn more about this trial

ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing (ACROBAT)

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