Hypertension and Atrial FibrillationACROBATNCT01748253
ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing (ACROBAT)
A study testing Telmisartan-amlodipine tablet administration group (morning) and Telmisartan-amlodipine tablet administration group (bedtime) in people with Hypertension and Atrial Fibrillation, run by Acrobat Trial Group at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension and Atrial Fibrillation
- What is being tested?
- Telmisartan-amlodipine tablet administration group (morning) and Telmisartan-amlodipine tablet administration group (bedtime)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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])
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Uchiyama Clinic
Jōetsu, Niigata Pref.
Kazuaki Uchiyama, +81-25-548-2400
About this study
Official title: ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing
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
- Being tested
- Telmisartan-amlodipine tablet administration group (morning), Telmisartan-amlodipine tablet administration group (bedtime)
- Medical subject headings
- Hypertension, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan-amlodipine tablet administration group (morning)Drug
Oral-administration of one telmisartan-amlodipine tablet once a day upon morning for 12 weeks
Telmisartan-amlodipine tablet administration group (bedtime)Drug
Oral-administration of one telmisartan-amlodipine tablet once a day at bedtime for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan-amlodipine tablet administration group (morning) | Active comparator | Not described Receives: Drug: Telmisartan-amlodipine tablet administration group (morning) |
| Telmisartan-amlodipine tablet administration group (bedtime) | Active comparator | Not described Receives: Drug: Telmisartan-amlodipine tablet administration group (bedtime) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour average blood pressure from baseline to Week 12.
Measured: Baseline and 12 weeks.
Secondary outcomes (11)
Change in blood pressures at night time, early-morning, and daytime from baseline to Week 12.
Measured: Baseline and 12 weeks.
Change in blood pressure at hospital visit from baseline to Week 12.
Measured: Baseline and 12 weeks.
Change in blood pressure at home from baseline to Week 12.
Measured: Baseline and 12 weeks.
Change in blood pressure control rate from baseline to Week 12.
Measured: Baseline and 12 weeks.
Change in blood pressure variability from baseline to Week 12.
Measured: Baseline and 12 weeks.
Change in laboratory parameters (blood insulin, hsTnT, PAI-1, and NT-ProBNP) from baseline to Week 12.
Measured: Baseline and 12 weeks.
Onset of Adverse events
Measured: Baseline and 12 weeks.
Onset of atrial fibrillation
Measured: Baseline and 12 weeks.
Pulse rate
Measured: Baseline and 12 weeks.
PWV value
Measured: Baseline and 12 weeks.
Clinical laboratory test results
Measured: Baseline and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension and Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acrobat Trial Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Kazuomi Kario, Study chair, Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748253
- Sponsor's protocol ID
- 0067
- Acronym
- ACROBAT
- Status last verified
- May 2013
- First submitted
- 16 Nov 2012
- Last updated
- 21 May 2013
- Results posted
- No
Publications
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.
PubMed 26989846
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing
- ClinicalTrials.gov ID
- NCT01748253
- Acronym / sponsor ID
- ACROBAT / 0067
- Conditions
- Hypertension and Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Acrobat Trial GroupResearch network
- Study start
- Nov 2012
- Primary completion
- Oct 2013 (estimated)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan-amlodipine tablet administration group (morning) | Active comparator | Drug: Telmisartan-amlodipine tablet administration group (morning) |
| Telmisartan-amlodipine tablet administration group (bedtime) | Active comparator | Drug: Telmisartan-amlodipine tablet administration group (bedtime) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- (average of 3 measurements obtained at a scheduled visit)
- (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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telmisartan-amlodipine tablet administration group (morning)Oral-administration of one telmisartan-amlodipine tablet once a day upon morning for 12 weeks | Drug | Telmisartan-amlodipine tablet administration group (morning) |
| Telmisartan-amlodipine tablet administration group (bedtime)Oral-administration of one telmisartan-amlodipine tablet once a day at bedtime for 12 weeks | Drug | Telmisartan-amlodipine tablet administration group (bedtime) |
Primary outcome
Change in 24-hour average blood pressure from baseline to Week 12.
Time frame: Baseline and 12 weeks.
11 secondary outcomes
Change in blood pressures at night time, early-morning, and daytime from baseline to Week 12.
Time frame: Baseline and 12 weeks.
Change in blood pressure at hospital visit from baseline to Week 12.
Time frame: Baseline and 12 weeks.
Change in blood pressure at home from baseline to Week 12.
Time frame: Baseline and 12 weeks.
Change in blood pressure control rate from baseline to Week 12.
Time frame: Baseline and 12 weeks.
Change in blood pressure variability from baseline to Week 12.
Time frame: Baseline and 12 weeks.
Change in laboratory parameters (blood insulin, hsTnT, PAI-1, and NT-ProBNP) from baseline to Week 12.
Time frame: Baseline and 12 weeks.
Onset of Adverse events
Time frame: Baseline and 12 weeks.
Onset of atrial fibrillation
Time frame: Baseline and 12 weeks.
Pulse rate
Time frame: Baseline and 12 weeks.
PWV value
Time frame: Baseline and 12 weeks.
Clinical laboratory test results
Time frame: Baseline and 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
- Derived from this study: PubMed 26989846Kario 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazuomi Kario study chair
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telmisartan-amlodipine tablet administration group (morning) and Telmisartan-amlodipine tablet administration group (bedtime) in people with Hypertension and Atrial Fibrillation, run by Acrobat Trial Group at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shinji Mitoma (+81-3-5312-5026, acrobat-study@sa-tt.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour average blood pressure from baseline to Week 12. (time frame: Baseline and 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01748253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2013.