Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate
NCT ID: NCT02612298
Last Updated: 2019-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
198 participants
INTERVENTIONAL
2015-08-31
2018-09-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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arotinolol
Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks
Arotinolol Hydrochloride
Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks.
Metoprolol
Metoprolol succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks.
Metoprolol succinate sustained-release tablet
Metoprolol succinate sustained-release tablet,oral, 23.75-71.25mg, qd for 12 weeks.
Interventions
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Arotinolol Hydrochloride
Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks.
Metoprolol succinate sustained-release tablet
Metoprolol succinate sustained-release tablet,oral, 23.75-71.25mg, qd for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged between 18-65 years old.
3. Signed informed consent.
Exclusion Criteria
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.
18 Years
65 Years
ALL
No
Sponsors
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Sumitomo Pharma (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yundai Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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China PLA General Hospital
Beijing, , China
Countries
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Other Identifiers
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DSPC-ALM-1401
Identifier Type: -
Identifier Source: org_study_id
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