NCT02612298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 23, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2018

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

3.1 years

First QC Date

September 2, 2015

Last Update Submit

April 15, 2019

Conditions

Essential Hypertension

Keywords

Essential HypertensionArotinololMorning Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Diastolic blood pressure

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

    12 weeks

Secondary Outcomes (9)

  • Systolic blood pressure

    12 weeks

  • Morning surge

    12 weeks

  • The increase rate of morning blood pressure

    12 weeks

  • Morning blood pressure (BP) by office BP measure

    12 weeks

  • Heart rate by office BP measure

    12 weeks

  • +4 more secondary outcomes

Other Outcomes (1)

  • Safety assessed by incidence rate of adverse events

    12 weeks

Study Arms (2)

arotinolol

EXPERIMENTAL

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

Drug: Arotinolol Hydrochloride

Metoprolol

ACTIVE COMPARATOR

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

Drug: Metoprolol succinate sustained-release tablet

Interventions

Arotinolol HydrochlorideDRUG

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

Also known as: Almarl
arotinolol
Metoprolol succinate sustained-release tabletDRUG

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

Also known as: Betaloc tablet
Metoprolol

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China PLA General Hospital

Beijing, 100039, China

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

arotinololAlmarlMetoprolol

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Yundai Chen, MD

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2015

First Posted

November 23, 2015

Study Start

August 1, 2015

Primary Completion

September 13, 2018

Study Completion

September 13, 2018

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

CN(1)