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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Pharma (Suzhou) Co., Ltd.

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.


Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Arotinolol Hydrochloride Drug: Metoprolol succinate sustained-release tablet Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate in Patients With Essential Hypertension
Actual Study Start Date : August 2015
Actual Primary Completion Date : September 13, 2018
Actual Study Completion Date : September 13, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: arotinolol
Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks
Drug: Arotinolol Hydrochloride
Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks.
Other Name: 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 Name: Betaloc tablet




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612298


Locations
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China
China PLA General Hospital
Beijing, China, 100039
Sponsors and Collaborators
Sumitomo Pharma (Suzhou) Co., Ltd.
Investigators
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Principal Investigator: Yundai Chen, MD Chinese PLA General Hospital
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Responsible Party: Sumitomo Pharma (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02612298    
Other Study ID Numbers: DSPC-ALM-1401
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Keywords provided by Sumitomo Pharma (Suzhou) Co., Ltd.:
Essential Hypertension
Arotinolol
Morning Blood Pressure
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Arotinolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Antagonists