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

• Status: Completed
• Trial end date: 2018-09-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
• Treatments: Arotinolol; Metoprolol

Criteria

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.