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Azilsartan Circadian and Sleep Pressure

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Sogo Rinsho Médéfi Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01762501
First received: December 18, 2012
Last updated: November 19, 2015
Last verified: November 2015
  Purpose
To determine the efficacy of Azilsartan 20 mg versus Amlodipine 5 mg oral administration once per day for 8 weeks in patients with grade I or grade II essential hypertension.

Condition Intervention
Hypertension
Drug: Azilsartan
Drug: Amlodipine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Azilsartan Circadian and Sleep Pressure - the 1st Study

Resource links provided by NLM:


Further study details as provided by Sogo Rinsho Médéfi Co., Ltd.:

Primary Outcome Measures:
  • Change in Nocturnal Systolic Blood Pressure Level [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

    Change at the end of a treatment period (Week 8) from the beginning point of an observation period

    *Nocturnal systolic blood pressure level: the mean value of systolic arterial pressure during night (during sleeping)



Secondary Outcome Measures:
  • Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

    Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) *The targeted value has been set as the median of the dipping rate, normal type of nocturnal blood pressure variation, rate of nocturnal blood pressure fall (10-20 percent)

    ** Rate of nocturnal blood pressure fall: calculated as (awake SBP-sleep SBP)/awake SBP


  • Change in Nocturnal Diastolic Blood Pressure Level [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)

  • Change in 24-hour Mean Systolic Blood Pressure Level [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)

  • Change in 24-hour Mean Diastolic Blood Pressure Level [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)


Enrollment: 957
Study Start Date: December 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azilsartan
Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks
Drug: Azilsartan
Azilsartan 20mg/day
Other Name: AZILVA Tablets
Active Comparator: Amlodipine
Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks
Drug: Amlodipine
Amlodipine 5mg/day
Other Name: Amlodin Tablets etc.

Detailed Description:

Treatment

<Run-in period> Use of any antihypertensives, including azilsartan and amlodipine, is prohibited during the run-in period.

<Treatment period> Subjects who are considered eligible for participation in the study based on the results of eligibility assessment during the run-in period will be randomized to the azilsartan 20 mg or amlodipine 5 mg group at a ratio of 1:1 according to the following stratification factors; the type of awake-sleep blood pressure variation determined based on the data from ABPM at the start of run-in, complication status (chronic kidney diseases [CKD], type 2 diabetes), age, and sex.

Subjects will start treatment with either antihypertensive after examination for the start of treatment (Week 0) and visit the study site every 2 weeks, 5 visits in total, until the end of treatment (Week 8).

Subjects will orally take azilsartan 20 mg or amlodipine 5 mg, according to their group allocation, once daily before or after breakfast in the morning.

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Grade I or II essential hypertension
  • The sitting systolic blood pressure is in term of 140-179 mmHg, or sitting diastolic blood pressure is in term of 90-109 mmHg at the both two time points at the beginning of the observation period and at the beginning of a treatment period (Week0)
  • 20 years old or older at the time of the informed consent
  • Able to give written informed consent before participating in the research
  • Therapeutic category during the observation period: Ambulatory

Exclusion Criteria:

  • Secondary hypertension, grade III hypertension (sitting systolic blood pressure greater than or equal to 180 mmHg or sitting diastolic blood pressure greater than or equal to 110 mmHg), malignant hypertension
  • More than 2 kinds of antihypertensive agents for treatment on the hypertension
  • History of taking following medicines within 2 weeks before start of the observation period.

When subject with taking any of the following medicine at the time of informed consent is included, stop to take the medicine for determined period after the informed consent.

I. Antihypertensive agents II. Antianginal agents III. Antiarrhythmic agents (except single time use of the lidocaine hydrochloride formulation for anesthesia) IV. Digitalis products

  • Less than 130 mmHg of mean 24-hour systolic blood pressure and less than 80 mmHg of mean 24-hour diastolic blood pressure at the start of the observation period.
  • History of following circulatory-related diseases or symptoms within 24 weeks before start of the observation period.

I. Cardiac disease: Myocardial infarction, coronary artery revascularization II. Cerebrovascular-disease: cerebral infarction, cerebral hemorrhage, transient ischemic attack III. Progressive hypertensive retinopathy: hemorrhage, exudation, or papilledema

  • History or complication with the following circulatory-related diseases; Valvular stenosis, atrial fibrillation, pharmacotherapy-required angina, congestion heart failure, or cardiac arrhythmia, or arteriosclerosis obliterans with symptoms of intermittent claudication et al
  • Day / night reversal
  • History of hypersensitivity or allergy to Azilsartan, Amlodipine, or related drugs
  • Participant in any other clinical research
  • Pregnant, possible to being pregnant, or lactating woman
  • Mal-control of blood pressure during informed consent to taking antihypertensive agent
  • Any those the investigator or other researchers consider as unsuitable
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762501

  Show 92 Study Locations
Sponsors and Collaborators
Sogo Rinsho Médéfi Co., Ltd.
Takeda
Investigators
Principal Investigator: Kazuo Kario Chief Professor of Division of Cardiovascular Medicine, Jichi Medical University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sogo Rinsho Médéfi Co., Ltd.
ClinicalTrials.gov Identifier: NCT01762501     History of Changes
Other Study ID Numbers: ACS1 
Study First Received: December 18, 2012
Results First Received: November 19, 2015
Last Updated: November 19, 2015
Health Authority: Japan: Institutional Review Board

Keywords provided by Sogo Rinsho Médéfi Co., Ltd.:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on September 30, 2016