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Completed

NCT Number: NCT02612298

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

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

China PLA General Hospital

Beijing, 100039, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with systolic blood pressure between 140-179mmHg and/or diastolic blood pressure between 90-109mmHg.
  • Aged between 18-65 years old.
  • Signed informed consent.

Exclusion criteria

  • Secondary hypertension
  • Patients who taking amiodarone over 200mg/day to control arrhythmia
  • Patients who taking class I antiarrhythmic drugs
  • Resting heart rate less than 60bpm
  • 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)
  • Severe heart failure: New York Heart Association (NYHA) functional class 2, 3, 4
  • Myocardial infarction or stroke in the last three months. Unstable angina pectoris in the last month.
  • Patients with asthma or chronic obstructive pulmonary disease.
  • Pregnancy and breast-feeding
  • Patients allergy to investigational drugs or have contraindication to investigational drugs.
  • Others unsuitable to participate in the study judged by investigator.

Treatment and study plan

Arotinolol Hydrochloride

Drug

Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks.

Other names: Almarl

Metoprolol succinate sustained-release tablet

Drug

Metoprolol succinate sustained-release tablet,oral, 23.75-71.25mg, qd for 12 weeks.

Other names: Betaloc tablet

Primary outcomes

  1. Diastolic blood pressure

    Time frame: 12 weeks

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

Secondary outcomes

  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 outcomes

  1. Safety assessed by incidence rate of adverse events

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Marubeni Pharmaceuticals (Suzhou) Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: ESAHOM

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 23, 2015
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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