Essential HypertensionNCT05947448
Efficacy and Safety of Mexartan Potassium Tablets (AZL-M) and Calcium Channel Blockers (CCB) in the Treatment of Adults With Essential Hypertension in Chinese Population: a National Multicenter, Prospective, Observational Study
An observational study of Essential Hypertension, run by Hasten Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a national multicenter, prospective, observational study. It is planned to enroll 1215 patients with newly diagnosed essential hypertension in 80 centers, and divide them into 3 groups according to different treatment plans given by doctors: AZL-M monotherapy group, CCB monotherapy group (amlodipine besylate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Azilsartan Medoxomil Potassium Tablet, Nifedipine Sustained -release Tablets and Levoamlodipine Maleate Table
- Type of treatment
- Pill or oral medicine
- How many people
- 1,215 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2024to 31 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: town hospital
Who may be able to join
- Age ≥ 18 years old (one year old);
- Patients diagnosed with essential hypertension;
- Did not receive any antihypertensive drug treatment for at least 3 months before enrollment;
- Eligible to use 80 mg once-daily AZL-M at baseline or CCB (amlodipine besylate tablets or nifedipine controlled-release tablets) or CCB (besylate Amlodipine tablets or nifedipine controlled-release tablets) + AZL-M 80 mg once-daily combination therapy; Volunteer to participate in this study, understand and sign the written informed consent.
Who cannot join
- Used antihypertensive drugs for indications other than hypertension within 3 months before enrollment;
- Has a history of alcoholism, drug abuse or illegal drug use;
- Pregnant, breastfeeding women, and those who plan to become pregnant in the near future;
- Life expectancy is less than one year; Participating in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Junbo Ge
Shanghai, Shanghai Municipality
Junbo Ge
About this study
This is a national multicenter, prospective, observational study. It is planned to enroll 1215 patients with newly diagnosed essential hypertension in 80 centers, and divide them into 3 groups according to different treatment plans given by doctors: AZL-M monotherapy group, CCB monotherapy group (amlodipine besylate tablets or nifedipine controlled-release tablets) and AZL-M+CCB (amlodipine besylate tablets or nifedipine controlled-release tablets) combined treatment group. Subjects were visited 4 times at baseline, 1 month, 3 months, and 6 months, and the following key indicators of subjects were measured according to the doctor's decision, and the measurement results were collected
- Conditions
- Essential Hypertension
- Being tested
- Azilsartan Medoxomil Potassium Tablet, Nifedipine Sustained -release Tablets, Levoamlodipine Maleate Table
- Keywords
- essential hypertension
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azilsartan Medoxomil Potassium TabletDrug
Azilsartan Medoxomil Potassium Tablet，80mg，qd，lasts six month
Nifedipine Sustained -release TabletsDrug
Nifedipine Sustained -release Tablets，qd，The maximum clinical dose，lasts six months；
Levoamlodipine Maleate TableDrug
Levoamlodipine Maleate Table，qd，The maximum clinical dose，lasts six months；
| Study group | Role | What they receive |
|---|---|---|
| AZL-M single drug group | Azilsartan Medoxomil Potassium Tablet，80mg，tablet，QD，six months Receives: Drug: Azilsartan Medoxomil Potassium Tablet | |
| CCB single drug group | Nifedipine Controller-release Tablets，clinical maximum tolerated dose，tablet，QD，six months；or Levoamlodipine Maleate Table，clinical maximum tolerated dose，tablet，QD，six months； Doctor choose a medication that is more suitable for patient treatment. Receives: Drug: Nifedipine Sustained -release Tablets; Drug: Levoamlodipine Maleate Table | |
| AZL-M + CCB drug group（Combined medication） | Nifedipine Controller-release Tablets，clinical maximum tolerated dose，tablet，QD，six months；and Levoamlodipine Maleate Table，clinical maximum tolerated dose，tablet，QD，six months； When the patient's upper pressure exceeds 160 Millimetre of mercury, the doctor will choose combination medication .CCB drug will be chosen either Nifedipine Controller-release Tablets or Levoamlodipine Maleate Table. Receives: Drug: Azilsartan Medoxomil Potassium Tablet; Drug: Nifedipine Sustained -release Tablets; Drug: Levoamlodipine Maleate Table |
What is being measured
The primary outcome is the main question the study is designed to answer.
the patient's blood pressure reached the target rate
Ø Compliance rate of systolic blood pressure (SBP) in the clinic: the proportion of subjects whose blood pressure dropped to sitting systolic blood pressure (sitSBP) <140 mmHg or compared with the baseline value of sitSBP ≥ 20mmHg;
Ø Compliance rate of diastolic blood pressure (DBP) in the clinic: the proportion of subjects whose blood pressure dropped to sitting diastolic blood pressure (sitDBP) <90 mmHg or compared with the baseline value of sitDBP decreased by ≥10mmHg;
Ø Achievement rate of both SBP and DBP in the clinic: the proportion of subjects who meet the SBP and DBP standards in the above clinics at the same time.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start22 Jan 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,215 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hasten Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947448
- Sponsor's protocol ID
- Ph4-HST-EDA-C-NIS-22-01
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Mexartan Potassium Tablets (AZL-M) and Calcium Channel Blockers (CCB) in the Treatment of Adults With Essential Hypertension in Chinese Population: a National Multicenter, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT05947448
- Acronym / sponsor ID
- Ph4-HST-EDA-C-NIS-22-01
- Conditions
- Essential Hypertension
- Keywords
- essential hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,215 participants (estimated)
- Lead sponsor
- Hasten Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jul 2023 (actual)
- 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.
This is a national multicenter, prospective, observational study. It is planned to enroll 1215 patients with newly diagnosed essential hypertension in 80 centers, and divide them into 3 groups according to different treatment plans given by doctors: AZL-M monotherapy group, CCB monotherapy group (amlodipine besylate tablets or nifedipine controlled-release tablets) and AZL-M+CCB (amlodipine besylate tablets or nifedipine controlled-release tablets) combined treatment group. Subjects were visited 4 times at baseline, 1 month, 3 months, and 6 months, and the following key indicators of subjects were measured according to the doctor's decision, and the measurement results were collected
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AZL-M single drug group | – | Drug: Azilsartan Medoxomil Potassium TabletAzilsartan Medoxomil Potassium Tablet，80mg，tablet，QD，six months |
| CCB single drug group | – | Drug: Nifedipine Sustained -release Tablets, Drug: Levoamlodipine Maleate TableNifedipine Controller-release Tablets，clinical maximum tolerated dose，tablet，QD，six months；or Levoamlodipine Maleate Table，clinical maximum tolerated dose，tablet，QD，six months； Doctor choose a medication that is more suitable for patient treatment. |
| AZL-M + CCB drug group（Combined medication） | – | Drug: Azilsartan Medoxomil Potassium Tablet, Drug: Nifedipine Sustained -release Tablets, Drug: Levoamlodipine Maleate TableNifedipine Controller-release Tablets，clinical maximum tolerated dose，tablet，QD，six months；and Levoamlodipine Maleate Table，clinical maximum tolerated dose，tablet，QD，six months； When the patient's upper pressure exceeds 160 Millimetre of mercury, the doctor will choose combination medication .CCB drug will be chosen either Nifedipine Controller-release Tablets or Levoamlodipine Maleate Table. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- town hospital
Key inclusion criteria (4 listed)
- Age ≥ 18 years old (one year old);
- Patients diagnosed with essential hypertension;
- Did not receive any antihypertensive drug treatment for at least 3 months before enrollment;
- Eligible to use 80 mg once-daily AZL-M at baseline or CCB (amlodipine besylate tablets or nifedipine controlled-release tablets) or CCB (besylate Amlodipine tablets or nifedipine controlled-release tablets) + AZL-M 80 mg once-daily combination therapy; Volunteer to participate in this study, understand and sign the written informed consent.
Key exclusion criteria (4 listed)
- Used antihypertensive drugs for indications other than hypertension within 3 months before enrollment;
- Has a history of alcoholism, drug abuse or illegal drug use;
- Pregnant, breastfeeding women, and those who plan to become pregnant in the near future;
- Life expectancy is less than one year; Participating in other clinical trials.
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 |
|---|---|---|
| Azilsartan Medoxomil Potassium TabletAzilsartan Medoxomil Potassium Tablet，80mg，qd，lasts six month | Drug | AZL-M + CCB drug group（Combined medication）, AZL-M single drug group |
| Nifedipine Sustained -release TabletsNifedipine Sustained -release Tablets，qd，The maximum clinical dose，lasts six months； | Drug | AZL-M + CCB drug group（Combined medication）, CCB single drug group |
| Levoamlodipine Maleate TableLevoamlodipine Maleate Table，qd，The maximum clinical dose，lasts six months； | Drug | AZL-M + CCB drug group（Combined medication）, CCB single drug group |
Primary outcome
the patient's blood pressure reached the target rate
Time frame: 6 months
Ø Compliance rate of systolic blood pressure (SBP) in the clinic: the proportion of subjects whose blood pressure dropped to sitting systolic blood pressure (sitSBP) <140 mmHg or compared with the baseline value of sitSBP ≥ 20mmHg; Ø Compliance rate of diastolic blood pressure (DBP) in the clinic: the proportion of subjects whose blood pressure dropped to sitting diastolic blood pressure (sitDBP) <90 mmHg or compared with the baseline value of sitDBP decreased by ≥10mmHg; Ø Achievement rate of both SBP and DBP in the clinic: the proportion of subjects who meet the SBP and DBP standards in the above clinics at the same time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Hypertension, run by Hasten Biopharmaceutical 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Apr 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Bo Ge, academician (+86 13901977506, ge.junbo@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the patient's blood pressure reached the target rate (time frame: 6 months). 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 1 Apr 2024.