Essential HypertensionPhase 4ESAHOMNCT02612298
Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate
A Phase 4 study testing Arotinolol Hydrochloride and Metoprolol succinate sustained-release tablet in people with Essential Hypertension, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Arotinolol Hydrochloride and Metoprolol succinate sustained-release tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to 13 Sep 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate in Patients With Essential Hypertension
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.
Read the 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.
- Conditions
- Essential Hypertension
- Being tested
- Arotinolol Hydrochloride, Metoprolol succinate sustained-release tablet
- Keywords
- Essential Hypertension, Arotinolol, Morning Blood Pressure
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arotinolol HydrochlorideDrug
Also called Almarl
Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks.
Metoprolol succinate sustained-release tabletDrug
Also called Betaloc tablet
Metoprolol succinate sustained-release tablet,oral, 23.75-71.25mg, qd for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| arotinolol | Experimental | Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks Receives: Drug: Arotinolol Hydrochloride |
| Metoprolol | Active comparator | Metoprolol succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks. Receives: Drug: Metoprolol succinate sustained-release tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastolic blood pressure
Changes in diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) after treatment
Measured: 12 weeks
Secondary outcomes (9)
Systolic blood pressure
Changes in systolic blood pressure measured by ABPM after 12 weeks of treatment
Measured: 12 weeks
Morning surge
Changes in morning surge after 12 weeks of treatment
Measured: 12 weeks
The increase rate of morning blood pressure
Changes in the increase rate of morning blood pressure after 12 weeks of treatment
Measured: 12 weeks
Morning blood pressure (BP) by office BP measure
Changes in morning blood pressure by office BP measure after 12 weeks of treatment
Measured: 12 weeks
Heart rate by office BP measure
Changes in heart rate by office BP measure after 12 weeks of treatment
Measured: 12 weeks
Pulse wave velocity (PWV)
Changes in PWV after 12 weeks of treatment
Measured: 12 weeks
Ankle-brachial index (ABI)
Changes in ABI after 12 weeks of treatment
Measured: 12 weeks
Albumin-to-creatinine ratio (ACR)
Changes in ACR after 12 weeks of treatment
Measured: 12 weeks
Glomerular filtration rate (GFR)
Changes in GFR after 12 weeks of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startAug 2015
- Primary completion13 Sep 2018
- Study completion13 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yundai Chen, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612298
- Sponsor's protocol ID
- DSPC-ALM-1401
- Acronym
- ESAHOM
- Status last verified
- Apr 2019
- First submitted
- 2 Sep 2015
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT02612298
- Acronym / sponsor ID
- ESAHOM / DSPC-ALM-1401
- Conditions
- Essential Hypertension
- Keywords
- Essential Hypertension, Arotinolol, Morning Blood Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2015 (actual)
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 23 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arotinolol | Experimental | Drug: Arotinolol HydrochlorideArotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks |
| Metoprolol | Active comparator | Drug: Metoprolol succinate sustained-release tabletMetoprolol succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arotinolol HydrochlorideAlso: AlmarlArotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks. | Drug | arotinolol |
| Metoprolol succinate sustained-release tabletAlso: Betaloc tabletMetoprolol succinate sustained-release tablet,oral, 23.75-71.25mg, qd for 12 weeks. | Drug | Metoprolol |
Primary outcome
Diastolic blood pressure
Time frame: 12 weeks
Changes in diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) after treatment
9 secondary outcomes
Systolic blood pressure
Time frame: 12 weeks
Morning surge
Time frame: 12 weeks
The increase rate of morning blood pressure
Time frame: 12 weeks
Morning blood pressure (BP) by office BP measure
Time frame: 12 weeks
Heart rate by office BP measure
Time frame: 12 weeks
Pulse wave velocity (PWV)
Time frame: 12 weeks
Ankle-brachial index (ABI)
Time frame: 12 weeks
Albumin-to-creatinine ratio (ACR)
Time frame: 12 weeks
Glomerular filtration rate (GFR)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yundai Chen, MD principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Arotinolol Hydrochloride and Metoprolol succinate sustained-release tablet in people with Essential Hypertension, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diastolic blood pressure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.