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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)

This study is currently recruiting participants.
Verified May 2013 by Acrobat Trial Group
Sponsor:
Information provided by (Responsible Party):
Acrobat Trial Group
ClinicalTrials.gov Identifier:
NCT01748253
First received: November 16, 2012
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Hypertension and Atrial Fibrillation
 Drug: Telmisartan-amlodipine tablet administration group (morning)
Drug: Telmisartan-amlodipine tablet administration group (bedtime)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Acrobat Trial Group:

Primary Outcome Measures:
  • Change in 24-hour average blood pressure from baseline to Week 12. [ Time Frame: Baseline and 12 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in blood pressures at night time, early-morning, and daytime from baseline to Week 12. [ Time Frame: Baseline and 12 weeks. ] [ Designated as safety issue: No ]
  • Change in blood pressure at hospital visit from baseline to Week 12. [ Time Frame: Baseline and 12 weeks. ] [ Designated as safety issue: No ]
  • Change in blood pressure at home from baseline to Week 12. [ Time Frame: Baseline and 12 weeks. ] [ Designated as safety issue: No ]
  • Change in blood pressure control rate from baseline to Week 12. [ Time Frame: Baseline and 12 weeks. ] [ Designated as safety issue: No ]
  • Change in blood pressure variability from baseline to Week 12. [ Time Frame: Baseline and 12 weeks. ] [ Designated as safety issue: No ]
  • Change in laboratory parameters (blood insulin, hsTnT, PAI-1, and NT-ProBNP) from baseline to Week 12. [ Time Frame: Baseline and 12 weeks. ] [ Designated as safety issue: No ]
  • Onset of Adverse events [ Time Frame: Baseline and 12 weeks. ] [ Designated as safety issue: Yes ]
  • Onset of atrial fibrillation [ Time Frame: Baseline and 12 weeks. ] [ Designated as safety issue: Yes ]
  • Pulse rate [ Time Frame: Baseline and 12 weeks. ] [ Designated as safety issue: Yes ]
  • PWV value [ Time Frame: Baseline and 12 weeks. ] [ Designated as safety issue: Yes ]
  • Clinical laboratory test results [ Time Frame: Baseline and 12 weeks. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: November 2012
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Telmisartan-amlodipine tablet administration group (morning) Drug: Telmisartan-amlodipine tablet administration group (morning)
Oral-administration of one telmisartan-amlodipine tablet once a day upon morning for 12 weeks
Active Comparator: Telmisartan-amlodipine tablet administration group (bedtime) Drug: Telmisartan-amlodipine tablet administration group (bedtime)
Oral-administration of one telmisartan-amlodipine tablet once a day at bedtime for 12 weeks

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748253

Contacts
Contact: Shinji Mitoma +81-3-5312-5026 acrobat-study@sa-tt.co.jp

Locations
Japan
Uchiyama Clinic Recruiting
Joetsu city, Niigata pref., Japan
Contact: Kazuaki Uchiyama     +81‐25‐548‐2400        
Sponsors and Collaborators
Acrobat Trial Group
Investigators
Study Chair: Kazuomi Kario Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
  More Information

No publications provided

Responsible Party: Acrobat Trial Group
ClinicalTrials.gov Identifier: NCT01748253     History of Changes
Other Study ID Numbers: 0067
Study First Received: November 16, 2012
Last Updated: May 20, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Atrial Fibrillation
Hypertension
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Amlodipine
Telmisartan
Benzoates
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 18, 2013