Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan-amlodipine tablet administration group (morning) | Active Comparator |
| |
| Telmisartan-amlodipine tablet administration group (bedtime) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan-amlodipine tablet administration group (morning) | Drug | Oral-administration of one telmisartan-amlodipine tablet once a day upon morning for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour average blood pressure from baseline to Week 12. | Baseline and 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressures at night time, early-morning, and daytime from baseline to Week 12. | Baseline and 12 weeks. | |
| Change in blood pressure at hospital visit from baseline to Week 12. | Baseline and 12 weeks. |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shinji Mitoma | Contact | +81-3-5312-5026 | acrobat-study@sa-tt.co.jp |
| Name | Affiliation | Role |
|---|---|---|
| Kazuomi Kario | Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uchiyama Clinic | Recruiting | Jōetsu | Niigata Pref. | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26989846 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Telmisartan-amlodipine tablet administration group (bedtime) | Drug | Oral-administration of one telmisartan-amlodipine tablet once a day at bedtime for 12 weeks |
|
| Change in blood pressure at home from baseline to Week 12. | Baseline and 12 weeks. |
| Change in blood pressure control rate from baseline to Week 12. | Baseline and 12 weeks. |
| Change in blood pressure variability from baseline to Week 12. | Baseline and 12 weeks. |
| Change in laboratory parameters (blood insulin, hsTnT, PAI-1, and NT-ProBNP) from baseline to Week 12. | Baseline and 12 weeks. |
| Onset of Adverse events | Baseline and 12 weeks. |
| Onset of atrial fibrillation | Baseline and 12 weeks. |
| Pulse rate | Baseline and 12 weeks. |
| PWV value | Baseline and 12 weeks. |
| Clinical laboratory test results | Baseline and 12 weeks. |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided