HypertensionPhase 2/3NCT04740840
Anti Inflammatory Treatment of Hypertension
A Phase 2/3 study testing Levamlodipine and Amlodipine in people with Hypertension, run by Affiliated Hospital of North Sichuan Medical College.
Trial summary
To investigate the anti-inflammatory effect of amlodipine and levamlodipine in the treatment of hypertension Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Levamlodipine and Amlodipine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2010to 2 May 2015
- Phase
- Phase 2/3
- 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
Who may be able to join
- ① In line with the diagnostic criteria of ISH2020 International Guidelines for Practice of Hypertension ② Age >18 years old, gender is not limited, during the treatment did not take other drugs that will affect blood pressure: such as antidepressants, oral contraceptives, Chinese herbal medicine, etc.; Voluntary participation and signing of informed consent, and can complete all the visit plan.
Who cannot join
- (1) Those who do not want to take blood tests; (2) Left ventricular ejection fraction < 50%, heart rate <50 beats/min; ③ Acute coronary syndrome (unstable angina pectoris and myocardial infarction); ④ valvular heart disease, congenital heart disease, etc.; Other infectious diseases and malignant tumors; ⑥ Bronchial asthma; ⑦ Abnormal liver function and renal dysfunction (ALT BBB 0 80U/L, CR BBB 1 442mmol/L); Autoimmune diseases or any serious and fatal diseases; ⑨ Receiving lipid-lowering therapy and oral vitamins or antioxidants; They are mentally ill, have no self-awareness, and are unable to express themselves or cooperate with others.
About this study
Official title: Comparison of Anti-inflammatory Effects of Amlodipine and Levamlodipine in Patients With Hypertension
To investigate the anti-inflammatory effect of amlodipine and levamlodipine in the treatment of hypertension
Read the detailed description
A total of 200 inpatients or outpatients in the Department of cardiovascular medicine of the third people's Hospital of Mianyang City from April 2021 to October 2021, who met the diagnostic criteria of ish2020 international hypertension practice guidelines, were selected and randomly divided into control group and experimental group, with 100 cases in each group. The control group was treated with amlodipine and the experimental group was treated with levoamlodipine. The changes of blood pressure and serum inflammatory factors were observed before and after treatment.
- Conditions
- Hypertension
- Being tested
- Levamlodipine, Amlodipine
- Keywords
- Levamlodipine, Amlodipine, Serum inflammatory factors, Anti inflammatory treatment
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevamlodipineDrug
According to the inclusion criteria of the trial, those who met the diagnosis of hypertension were randomly divided into the experimental group and the control group. The experimental group was treated with 2.5mg levamlodipine to lower blood pressure. Abdominal blood was emptying before the start of the trial and at the first and third month of medication.Data on CRP, TNF-α, IL-6, Lp-PLA2 and ATP were collected.
AmlodipineDrug
According to the inclusion criteria, patients who met the diagnosis of hypertension were randomly divided into the experimental group and the control group. The experimental group was given 5mg amlodipine to lower blood pressure. Fasting blood was collected before the trial and during the first and third months of treatment. CRP, TNF-α, IL-6, Lp-PLA2 and ATP data were collected.
| Study group | Role | What they receive |
|---|---|---|
| Levamlodipine group | Experimental | Blood pressure lowering therapy with 2.5mg levamlodipine, plus metoprolol succinate Receives: Drug: Levamlodipine |
| Amlodipine group | Sham comparator | To receive 5mg amlodipine to lower blood pressure, plus metoprolol succinate Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
After treatment, the blood pressure control of L-amlodipine group was better than that of amlodipine group
Measured: One month after treatment
the serum inflammatory factor level of L-amlodipine group was lower than that of amlodipine group
Measured: One month after treatment
Serum ATP level can be used to evaluate the anti-inflammatory effect of hypertension drugs
Measured: One month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 May 2010
- Primary completion2 Apr 2012
- Study completion2 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of North Sichuan Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospitals affiliated to the China PLA General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740840
- Sponsor's protocol ID
- AHNorthSichuanMC
- Status last verified
- Feb 2021
- First submitted
- 4 Feb 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anti-inflammatory Effects of Amlodipine and Levamlodipine in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT04740840
- Acronym / sponsor ID
- AHNorthSichuanMC
- Conditions
- Hypertension
- Keywords
- Levamlodipine, Amlodipine, Serum inflammatory factors, Anti inflammatory treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Affiliated Hospital of North Sichuan Medical CollegeUniversity, hospital or other
- Collaborators
- First Hospitals affiliated to the China PLA General Hospital
- Study start
- 1 May 2010 (actual)
- Primary completion
- 2 Apr 2012 (actual)
- Study completion
- 2 May 2015 (actual)
- First posted
- 5 Feb 2021 (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.
To investigate the anti-inflammatory effect of amlodipine and levamlodipine in the treatment of hypertension
Detailed description
A total of 200 inpatients or outpatients in the Department of cardiovascular medicine of the third people's Hospital of Mianyang City from April 2021 to October 2021, who met the diagnostic criteria of ish2020 international hypertension practice guidelines, were selected and randomly divided into control group and experimental group, with 100 cases in each group. The control group was treated with amlodipine and the experimental group was treated with levoamlodipine. The changes of blood pressure and serum inflammatory factors were observed before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levamlodipine group | Experimental | Drug: LevamlodipineBlood pressure lowering therapy with 2.5mg levamlodipine, plus metoprolol succinate |
| Amlodipine group | Sham comparator | Drug: AmlodipineTo receive 5mg amlodipine to lower blood pressure, plus metoprolol succinate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ① In line with the diagnostic criteria of ISH2020 International Guidelines for Practice of Hypertension ② Age >18 years old, gender is not limited, during the treatment did not take other drugs that will affect blood pressure: such as antidepressants, oral contraceptives, Chinese herbal medicine, etc.; Voluntary participation and signing of informed consent, and can complete all the visit plan.
Key exclusion criteria (1 listed)
- (1) Those who do not want to take blood tests; (2) Left ventricular ejection fraction < 50%, heart rate <50 beats/min; ③ Acute coronary syndrome (unstable angina pectoris and myocardial infarction); ④ valvular heart disease, congenital heart disease, etc.; Other infectious diseases and malignant tumors; ⑥ Bronchial asthma; ⑦ Abnormal liver function and renal dysfunction (ALT BBB 0 80U/L, CR BBB 1 442mmol/L); Autoimmune diseases or any serious and fatal diseases; ⑨ Receiving lipid-lowering therapy and oral vitamins or antioxidants; They are mentally ill, have no self-awareness, and are unable to express themselves or cooperate with others.
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 |
|---|---|---|
| LevamlodipineAccording to the inclusion criteria of the trial, those who met the diagnosis of hypertension were randomly divided into the experimental group and the control group. The experimental group was treated with 2.5mg levamlodipine to lower blood pressure. Abdominal blood was emptying before the start of the trial and at the first and third month of medication.Data on CRP, TNF-α, IL-6, Lp-PLA2 and ATP were collected. | Drug | Levamlodipine group |
| AmlodipineAccording to the inclusion criteria, patients who met the diagnosis of hypertension were randomly divided into the experimental group and the control group. The experimental group was given 5mg amlodipine to lower blood pressure. Fasting blood was collected before the trial and during the first and third months of treatment. CRP, TNF-α, IL-6, Lp-PLA2 and ATP data were collected. | Drug | Amlodipine group |
Primary outcome
After treatment, the blood pressure control of L-amlodipine group was better than that of amlodipine group
Time frame: One month after treatment
the serum inflammatory factor level of L-amlodipine group was lower than that of amlodipine group
Time frame: One month after treatment
Serum ATP level can be used to evaluate the anti-inflammatory effect of hypertension drugs
Time frame: One month after treatment
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 5 Feb 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Levamlodipine and Amlodipine in people with Hypertension, run by Affiliated Hospital of North Sichuan Medical College.
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 1 inclusion and 1 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 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
After treatment, the blood pressure control of L-amlodipine group was better than that of amlodipine group (time frame: One month after treatment). The study lists 3 primary outcomes in all. 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 5 Feb 2021.