Essential Hypertension
Conditions
Keywords
Essential Hypertension, Arotinolol, Morning Blood Pressure
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.
Interventions
Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks.
DRUGMetoprolol succinate sustained-release tablet
Metoprolol succinate sustained-release tablet,oral, 23.75-71.25mg, qd for 12 weeks.
Sponsors
Sumitomo Pharma (Suzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic blood pressure | 12 weeks | Changes in diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate by office BP measure | 12 weeks | Changes in heart rate by office BP measure after 12 weeks of treatment |
| Pulse wave velocity (PWV) | 12 weeks | Changes in PWV after 12 weeks of treatment |
| Ankle-brachial index (ABI) | 12 weeks | Changes in ABI after 12 weeks of treatment |
| Systolic blood pressure | 12 weeks | Changes in systolic blood pressure measured by ABPM 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 |
| Morning blood pressure (BP) by office BP measure | 12 weeks | Changes in morning blood pressure by office BP measure after 12 weeks of treatment |
| Albumin-to-creatinine ratio (ACR) | 12 weeks | Changes in ACR after 12 weeks of treatment |
| Glomerular filtration rate (GFR) | 12 weeks | Changes in GFR after 12 weeks of treatment |
| Morning surge | 12 weeks | Changes in morning surge after 12 weeks of treatment |
Other
| Measure | Time frame |
|---|---|
| Safety assessed by incidence rate of adverse events | 12 weeks |
Countries
China
Outcome results
None listed