Clinical trial NCT02612298: Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate
Official title: Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Hypertension
Keywords: Essential Hypertension
Arotinolol
Morning Blood Pressure
Lead sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-11-23
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Diastolic blood pressure
timeFrame: 12 weeks
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: 12 weeks
measure: Morning surge
timeFrame: 12 weeks
measure: The increase rate of morning blood pressure
timeFrame: 12 weeks
measure: Morning blood pressure (BP) by office BP measure
timeFrame: 12 weeks
measure: Heart rate by office BP measure
timeFrame: 12 weeks
measure: Pulse wave velocity (PWV)
timeFrame: 12 weeks
measure: Ankle-brachial index (ABI)
timeFrame: 12 weeks
measure: Albumin-to-creatinine ratio (ACR)
timeFrame: 12 weeks
measure: Glomerular filtration rate (GFR)
timeFrame: 12 weeks
Other outcomes:
measure: Safety assessed by incidence rate of adverse events
timeFrame: 12 weeks
Locations:
city: Beijing
country: China
facility: China PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Yundai Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: