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

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

Tracking Information
First Submitted Date  ICMJE September 2, 2015
First Posted Date  ICMJE November 23, 2015
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date September 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Essential Hypertension
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2019)
198
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2015)
200
Actual Study Completion Date  ICMJE September 13, 2018
Actual Primary Completion Date September 13, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02612298
Other Study ID Numbers  ICMJE DSPC-ALM-1401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Study Sponsor  ICMJE Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yundai Chen, MD Chinese PLA General Hospital
PRS Account Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP