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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)

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ClinicalTrials.gov Identifier: NCT01748253
Recruitment Status : Unknown
Verified May 2013 by Acrobat Trial Group.
Recruitment status was:  Recruiting
First Posted : December 12, 2012
Last Update Posted : May 21, 2013
Sponsor:
Information provided by (Responsible Party):
Acrobat Trial Group

Tracking Information
First Submitted Date  ICMJE November 16, 2012
First Posted Date  ICMJE December 12, 2012
Last Update Posted Date May 21, 2013
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
Change in 24-hour average blood pressure from baseline to Week 12. [ Time Frame: Baseline and 12 weeks. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01748253 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing (ACROBAT)
Official Title  ICMJE ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension and Atrial Fibrillation
Intervention  ICMJE
  • Drug: 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 (bedtime)
    Oral-administration of one telmisartan-amlodipine tablet once a day at bedtime for 12 weeks
Study Arms  ICMJE
  • Active Comparator: Telmisartan-amlodipine tablet administration group (morning)
    Intervention: Drug: Telmisartan-amlodipine tablet administration group (morning)
  • Active Comparator: Telmisartan-amlodipine tablet administration group (bedtime)
    Intervention: Drug: Telmisartan-amlodipine tablet administration group (bedtime)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 11, 2012)
80
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01748253
Other Study ID Numbers  ICMJE 0067
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acrobat Trial Group
Study Sponsor  ICMJE Acrobat Trial Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kazuomi Kario Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
PRS Account Acrobat Trial Group
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP