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

NCT ID: NCT01748253

Last Updated: 2013-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30

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.

Conditions

Hypertension and Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telmisartan-amlodipine tablet administration group (morning)

Group Type: ACTIVE_COMPARATOR

Telmisartan-amlodipine tablet administration group (morning)

Intervention Type: DRUG

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

Telmisartan-amlodipine tablet administration group (bedtime)

Group Type: ACTIVE_COMPARATOR

Telmisartan-amlodipine tablet administration group (bedtime)

Intervention Type: DRUG

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

Interventions

Telmisartan-amlodipine tablet administration group (morning)

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

Intervention Type: DRUG

Telmisartan-amlodipine tablet administration group (bedtime)

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

Intervention Type: DRUG

Eligibility Criteria

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, 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])

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.

Exclusion Criteria

1. Patients with serious liver and/or kidney disease

2. Patients with 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acrobat Trial Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kazuomi Kario

Role: STUDY_CHAIR

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

Locations

Uchiyama Clinic

Jōetsu, Niigata Pref., Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Shinji Mitoma

Role: CONTACT

acrobat-study@sa-tt.co.jp

+81-3-5312-5026

Facility Contacts

Kazuaki Uchiyama

Role: primary

+81-25-548-2400

References

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.

Reference Type: DERIVED

PMID: 26989846 (View on PubMed)

Other Identifiers

0067

Identifier Type: -

Identifier Source: org_study_id