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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: Arotinolol Hydrochloride
* Drug: Metoprolol succinate sustained-release tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arotinolol<br>Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks | Drug: Arotinolol Hydrochloride<br>* Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks.<br>* Other names: Almarl;|
| Active Comparator: Metoprolol<br>Metoprolol succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks. | Drug: Metoprolol succinate sustained-release tablet<br>* Metoprolol succinate sustained-release tablet,oral, 23.75-71.25mg, qd for 12 weeks.<br>* Other names: Betaloc tablet;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Essential Hypertension, Arotinolol, Morning Blood Pressure