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

Last updated: April 15, 2019
Sponsor: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Overall Status: Completed

Phase

4

Condition

Stress

Circulation Disorders

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT02612298
DSPC-ALM-1401
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with systolic blood pressure between 140-179mmHg and/or diastolic bloodpressure between 90-109mmHg.

  2. Aged between 18-65 years old.

  3. Signed informed consent.

Exclusion

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 alanineaminotransferase) (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 inthe 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 investigationaldrugs.

  11. Others unsuitable to participate in the study judged by investigator.

Study Design

Total Participants: 198
Study Start date:
August 01, 2015
Estimated Completion Date:
September 13, 2018

Study 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.

Connect with a study center

  • China PLA General Hospital

    Beijing, 100039
    China

    Site Not Available

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