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

Hypertension and Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01748253
• Other study ID #: 0067
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2012
• Last updated: May 20, 2013
• Start date: November 2012

Study information

• Verified date: May 2013
• Source: Acrobat Trial Group
• Contact: Shinji Mitoma
• Phone: +81-3-5312-5026
• Email: acrobat-study[@]sa-tt.co.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hypertension
• Hypertension and Atrial Fibrillation

Intervention

Drug:
• Telmisartan-amlodipine tablet administration group (morning)
Oral-administration of one telmisartan-amlodipine tablet once a day upon morning for 12 weeks
• Telmisartan-amlodipine tablet administration group (bedtime)
Oral-administration of one telmisartan-amlodipine tablet once a day at bedtime for 12 weeks

Locations

Country	Name	City	State
Japan	Uchiyama Clinic	Joetsu city	Niigata pref.

Sponsors (1)

Lead Sponsor	Collaborator
Acrobat Trial Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24-hour average blood pressure from baseline to Week 12.		Baseline and 12 weeks.	No
Secondary	Change in blood pressures at night time, early-morning, and daytime from baseline to Week 12.		Baseline and 12 weeks.	No
Secondary	Change in blood pressure at hospital visit from baseline to Week 12.		Baseline and 12 weeks.	No
Secondary	Change in blood pressure at home from baseline to Week 12.		Baseline and 12 weeks.	No
Secondary	Change in blood pressure control rate from baseline to Week 12.		Baseline and 12 weeks.	No
Secondary	Change in blood pressure variability from baseline to Week 12.		Baseline and 12 weeks.	No
Secondary	Change in laboratory parameters (blood insulin, hsTnT, PAI-1, and NT-ProBNP) from baseline to Week 12.		Baseline and 12 weeks.	No
Secondary	Onset of Adverse events		Baseline and 12 weeks.	Yes
Secondary	Onset of atrial fibrillation		Baseline and 12 weeks.	Yes
Secondary	Pulse rate		Baseline and 12 weeks.	Yes
Secondary	PWV value		Baseline and 12 weeks.	Yes
Secondary	Clinical laboratory test results		Baseline and 12 weeks.	Yes