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

• ClinicalTrials.gov Identifier: NCT02612298
• Recruitment Status: Completed
• First Posted: November 23, 2015
• Last Update Posted: April 17, 2019
• Sponsor: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
• Information provided by (Responsible Party): Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Tracking Information

• First Submitted Date: September 2, 2015
• First Posted Date: November 23, 2015
• Last Update Posted Date: April 17, 2019
• Actual Study Start Date: August 2015
• Actual Primary Completion Date: September 13, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 20, 2015)

Diastolic blood pressure [ Time Frame: 12 weeks ]

Changes in diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) after treatment

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 20, 2015)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures (submitted: November 20, 2015): Safety assessed by incidence rate of adverse events [ Time Frame: 12 weeks ]
• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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

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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Essential Hypertension

Intervention

• Drug: Arotinolol Hydrochloride
  Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks.
  Other Name: Almarl
• Drug: Metoprolol succinate sustained-release tablet
  Metoprolol succinate sustained-release tablet,oral, 23.75-71.25mg, qd for 12 weeks.
  Other Name: Betaloc tablet

Study Arms

• Experimental: arotinolol
  Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks
  Intervention: Drug: Arotinolol Hydrochloride
• Active Comparator: Metoprolol
  Metoprolol succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks.
  Intervention: Drug: Metoprolol succinate sustained-release tablet

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 15, 2019): 198
• Original Estimated Enrollment (submitted: November 20, 2015): 200
• Actual Study Completion Date: September 13, 2018
• Actual Primary Completion Date: September 13, 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02612298
• Other Study ID Numbers: DSPC-ALM-1401
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
• Study Sponsor: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Yundai Chen, MD; Chinese PLA General Hospital

• PRS Account: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
• Verification Date: April 2019