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History of Changes for Study: NCT02612298
Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate (ESAHOM)
Latest version (submitted April 15, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 20, 2015 None (earliest Version on record)
2 October 13, 2016 Study Status
3 April 15, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT02612298
Submitted Date:  November 20, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: DSPC-ALM-1401
Brief Title: Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate (ESAHOM)
Official Title: Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate in Patients With Essential Hypertension
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2015
Overall Status: Recruiting
Study Start: August 2015
Primary Completion: December 2017 [Anticipated]
Study Completion: December 2018 [Anticipated]
First Submitted: September 2, 2015
First Submitted that
Met QC Criteria:
November 20, 2015
First Posted: November 23, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 20, 2015
Last Update Posted: November 23, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Essential Hypertension
Keywords: Essential Hypertension
Arotinolol
Morning Blood Pressure
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: arotinolol
Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks
Drug: Arotinolol Hydrochloride
Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks.
Other Names:
  • Almarl
Active Comparator: Metoprolol
Metoprolol succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks.
Drug: Metoprolol succinate sustained-release tablet
Metoprolol succinate sustained-release tablet,oral, 23.75-71.25mg, qd for 12 weeks.
Other Names:
  • Betaloc tablet
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Diastolic blood pressure
[ Time Frame: 12 weeks ]

Changes in diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) after treatment
Secondary Outcome Measures:
1. Systolic blood pressure
[ Time Frame: 12 weeks ]

Changes in systolic blood pressure measured by ABPM after 12 weeks of treatment
2. Morning surge
[ Time Frame: 12 weeks ]

Changes in morning surge after 12 weeks of treatment
3. 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
4. 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
5. Heart rate by office BP measure
[ Time Frame: 12 weeks ]

Changes in heart rate by office BP measure after 12 weeks of treatment
6. Pulse wave velocity (PWV)
[ Time Frame: 12 weeks ]

Changes in PWV after 12 weeks of treatment
7. Ankle-brachial index (ABI)
[ Time Frame: 12 weeks ]

Changes in ABI after 12 weeks of treatment
8. Albumin-to-creatinine ratio (ACR)
[ Time Frame: 12 weeks ]

Changes in ACR after 12 weeks of treatment
9. Glomerular filtration rate (GFR)
[ Time Frame: 12 weeks ]

Changes in GFR after 12 weeks of treatment
Other Outcome Measures:
1. Safety assessed by incidence rate of adverse events
[ Time Frame: 12 weeks ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Yundai Chen, MD
Telephone: +86 010 55499209
Email: cyundai@medmail.com.cn
Study Officials: Yundai Chen, MD
Principal Investigator
Chinese PLA General Hospital
Locations: China
China PLA General Hospital
[Recruiting]
Beijing, China, 100039
Contact:Contact: Yundai Chen, MD
Contact:Contact: Yundai Chen, MD +86 010 55499209 cyundai@medmail.com.cn
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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