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

April 15, 2019 updated by: Sumitomo Pharma (Suzhou) Co., Ltd.

Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate in Patients With Essential Hypertension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100039
        • China PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: arotinolol
Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks
Drug: Arotinolol Hydrochloride
Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks.
Other Names:
  • Almarl
ACTIVE_COMPARATOR: Metoprolol
Metoprolol succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks.
Drug: Metoprolol succinate sustained-release tablet
Metoprolol succinate sustained-release tablet,oral, 23.75-71.25mg, qd for 12 weeks.
Other Names:
  • Betaloc tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diastolic blood pressure
Time Frame: 12 weeks
Changes in diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) after treatment
12 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Safety assessed by incidence rate of adverse events
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sumitomo Pharma (Suzhou) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2015

Primary Completion (ACTUAL)

September 13, 2018

Study Completion (ACTUAL)

September 13, 2018

Study Registration Dates

First Submitted

September 2, 2015

First Submitted That Met QC Criteria

November 20, 2015

First Posted (ESTIMATE)

November 23, 2015

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSPC-ALM-1401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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