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

Phase 4

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Metoprolol succinate sustained-release tablet; Drug: Arotinolol Hydrochloride

• Registration Number: NCT02612298
• Lead Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-11-20
• Study First Posted: 2015-11-23
• Primary Completion: 2018-09-13
• Study Completion: 2018-09-13
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metoprolol	Metoprolol succinate sustained-release tablet	Metoprolol succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks.
arotinolol	Arotinolol Hydrochloride	Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks

Primary Outcome Measures

Name	Time	Method
Diastolic blood pressure	12 weeks	Changes in diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) after treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

China PLA General Hospital; 🇨🇳 Beijing, China