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Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate (ESAHOM)

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Arotinolol Hydrochloride
Metoprolol succinate sustained-release tablet
Sponsored by
Sumitomo Pharma (Suzhou) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Essential Hypertension, Arotinolol, Morning Blood Pressure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with systolic blood pressure between 140-179mmHg and/or diastolic blood pressure between 90-109mmHg.
  2. Aged between 18-65 years old.
  3. Signed informed consent.

Exclusion Criteria:

  1. Secondary hypertension
  2. Patients who taking amiodarone over 200mg/day to control arrhythmia
  3. Patients who taking class I antiarrhythmic drugs
  4. Resting heart rate less than 60bpm
  5. Serious liver and kidney disease: aspartate aminotransferase (AST) or alanine aminotransferase) (ALT)>2.5 times upper limit of normal; serum creatinine>3mg/dl (265umol/L)
  6. Severe heart failure: New York Heart Association (NYHA) functional class 2, 3, 4
  7. Myocardial infarction or stroke in the last three months. Unstable angina pectoris in the last month.
  8. Patients with asthma or chronic obstructive pulmonary disease.
  9. Pregnancy and breast-feeding
  10. Patients allergy to investigational drugs or have contraindication to investigational drugs.
  11. Others unsuitable to participate in the study judged by investigator.

Sites / Locations

  • China PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

arotinolol

Metoprolol

Arm Description

Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks

Metoprolol succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks.

Outcomes

Primary Outcome Measures

Diastolic blood pressure
Changes in diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) after treatment

Secondary Outcome Measures

Systolic blood pressure
Changes in systolic blood pressure measured by ABPM after 12 weeks of treatment
Morning surge
Changes in morning surge after 12 weeks of treatment
The increase rate of morning blood pressure
Changes in the increase rate of morning blood pressure after 12 weeks of treatment
Morning blood pressure (BP) by office BP measure
Changes in morning blood pressure by office BP measure after 12 weeks of treatment
Heart rate by office BP measure
Changes in heart rate by office BP measure after 12 weeks of treatment
Pulse wave velocity (PWV)
Changes in PWV after 12 weeks of treatment
Ankle-brachial index (ABI)
Changes in ABI after 12 weeks of treatment
Albumin-to-creatinine ratio (ACR)
Changes in ACR after 12 weeks of treatment
Glomerular filtration rate (GFR)
Changes in GFR after 12 weeks of treatment

Full Information

First Posted
September 2, 2015
Last Updated
April 15, 2019
Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02612298
Brief Title
Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate
Acronym
ESAHOM
Official Title
Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate in Patients With Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
September 13, 2018 (Actual)
Study Completion Date
September 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy and safety of Arotinolol Hydrochloride and Metoprolol succinate on morning blood pressure, heart rate and target organ damage in patients with essential hypertension. To provide evidence for hypertension treatment. A group: Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks. B group: Metoprolol succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks.
Detailed Description
Compare the efficacy and safety of Arotinolol Hydrochloride and Metoprolol succinate on morning blood pressure, heart rate and target organ damage in patients with essential hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Essential Hypertension, Arotinolol, Morning Blood Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
arotinolol
Arm Type
Experimental
Arm Description
Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks
Arm Title
Metoprolol
Arm Type
Active Comparator
Arm Description
Metoprolol succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Arotinolol Hydrochloride
Other Intervention Name(s)
Almarl
Intervention Description
Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Metoprolol succinate sustained-release tablet
Other Intervention Name(s)
Betaloc tablet
Intervention Description
Metoprolol succinate sustained-release tablet,oral, 23.75-71.25mg, qd for 12 weeks.
Primary Outcome Measure Information:
Title
Diastolic blood pressure
Description
Changes in diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) after treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Description
Changes in systolic blood pressure measured by ABPM after 12 weeks of treatment
Time Frame
12 weeks
Title
Morning surge
Description
Changes in morning surge after 12 weeks of treatment
Time Frame
12 weeks
Title
The increase rate of morning blood pressure
Description
Changes in the increase rate of morning blood pressure after 12 weeks of treatment
Time Frame
12 weeks
Title
Morning blood pressure (BP) by office BP measure
Description
Changes in morning blood pressure by office BP measure after 12 weeks of treatment
Time Frame
12 weeks
Title
Heart rate by office BP measure
Description
Changes in heart rate by office BP measure after 12 weeks of treatment
Time Frame
12 weeks
Title
Pulse wave velocity (PWV)
Description
Changes in PWV after 12 weeks of treatment
Time Frame
12 weeks
Title
Ankle-brachial index (ABI)
Description
Changes in ABI after 12 weeks of treatment
Time Frame
12 weeks
Title
Albumin-to-creatinine ratio (ACR)
Description
Changes in ACR after 12 weeks of treatment
Time Frame
12 weeks
Title
Glomerular filtration rate (GFR)
Description
Changes in GFR after 12 weeks of treatment
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Safety assessed by incidence rate of adverse events
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with systolic blood pressure between 140-179mmHg and/or diastolic blood pressure between 90-109mmHg. Aged between 18-65 years old. Signed informed consent. Exclusion Criteria: Secondary hypertension Patients who taking amiodarone over 200mg/day to control arrhythmia Patients who taking class I antiarrhythmic drugs Resting heart rate less than 60bpm Serious liver and kidney disease: aspartate aminotransferase (AST) or alanine aminotransferase) (ALT)>2.5 times upper limit of normal; serum creatinine>3mg/dl (265umol/L) Severe heart failure: New York Heart Association (NYHA) functional class 2, 3, 4 Myocardial infarction or stroke in the last three months. Unstable angina pectoris in the last month. Patients with asthma or chronic obstructive pulmonary disease. Pregnancy and breast-feeding Patients allergy to investigational drugs or have contraindication to investigational drugs. Others unsuitable to participate in the study judged by investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yundai Chen, MD
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China PLA General Hospital
City
Beijing
ZIP/Postal Code
100039
Country
China

12. IPD Sharing Statement

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Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate

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