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

Essential Hypertension Clinical Trial

— ESAHOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612298
• Other study ID #: DSPC-ALM-1401
• Status: Completed
• Phase: Phase 4
• Start date: August 2015
• Est. completion date: September 13, 2018

Study information

• Verified date: April 2019
• Source: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: September 13, 2018
• Est. primary completion date: September 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	China PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety assessed by incidence rate of adverse events		12 weeks
Primary	Diastolic blood pressure	Changes in diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) after treatment	12 weeks
Secondary	Systolic blood pressure	Changes in systolic blood pressure measured by ABPM after 12 weeks of treatment	12 weeks
Secondary	Morning surge	Changes in morning surge after 12 weeks of treatment	12 weeks
Secondary	The increase rate of morning blood pressure	Changes in the increase rate of morning blood pressure after 12 weeks of treatment	12 weeks
Secondary	Morning blood pressure (BP) by office BP measure	Changes in morning blood pressure by office BP measure after 12 weeks of treatment	12 weeks
Secondary	Heart rate by office BP measure	Changes in heart rate by office BP measure after 12 weeks of treatment	12 weeks
Secondary	Pulse wave velocity (PWV)	Changes in PWV after 12 weeks of treatment	12 weeks
Secondary	Ankle-brachial index (ABI)	Changes in ABI after 12 weeks of treatment	12 weeks
Secondary	Albumin-to-creatinine ratio (ACR)	Changes in ACR after 12 weeks of treatment	12 weeks
Secondary	Glomerular filtration rate (GFR)	Changes in GFR after 12 weeks of treatment	12 weeks