Primary HypertensionLEADERNCT01844570
Levamlodipine Maleate or Amlodipine Besylate for Treatment of Hypertension: A Comparative Effectiveness Research
An observational study of Primary Hypertension, run by Peking University First Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether the effectiveness of levamlodipine maleate (xuanning) is noninferior to amlodipine besylate (Norvasc) in treatment of hypertension in a Chinese primary hypertension population. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Primary Hypertension
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Dec 2015
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 eligible sites(including primary care clinic and tertiary hospitals) over the country will participate. Each center will collect patients who fit the recruitment standard in chronological order.
Who may be able to join
- systolic pressure ≥140mmHg or diastolic pressure ≥90mmHg or receiving antihypertensive drug treatment
- Patient himself/herself or his/her family member has already signed the informed consent form
- Patient is fit for use of Levamlodipine Maleate or amlodipine besylate
- Age≥45
Who cannot join
- patient with secondary hypertension
- patients who has suffered from myocardial infarction or stroke within the latest 3 months
- patients who has obvious intelligence、hearing and limb's activity disability
- Patients with severe disease, with a life expectancy of less than two years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Levamlodipine Maleate (Xuanning) or Amlodipine Besylate (Norvasc) for Treatment of Hypertension: A Comparative Effectiveness Research
The purpose of this study is to determine whether the effectiveness of levamlodipine maleate (xuanning) is noninferior to amlodipine besylate (Norvasc) in treatment of hypertension in a Chinese primary hypertension population.
Read the detailed description
It is a multicenter, prospective cohort study with large sample size. It is to evaluate the effect on the incidence of cardiovascular and cerebrovascular endpoint events and blood pressure control in hypertensive patients who use Levamlodipine Maleate (Xuanning) or amlodipine besylate(Norvasc).Xuanning group and Norvasc group will recruit 5000 patients respectively. Each site will recruit patients in chronological order；patients who participate will finish the two-year follow up(1,2,3,6,12,18,24 months after recruitment) and relevant data will be recorded. Baseline data will be analyzed to evaluate the equilibrium between two or more groups (such as the number of options). Logistic regression and propensity scores (PS) would be used to match major indicators of effectiveness and safety indicators using matching method baseline data.
- Conditions
- Primary 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.
| Study group | Role | What they receive |
|---|---|---|
| Levamlodipine Maleate (Xuanning) | Primary hypertensive patients who take Levamlodipine Maleate (Xuanning) as the only anti-hypertensive medication or one of their medications | |
| Amlodipine Besylate (Norvasc) | Primary hypertensive patients who take Amlodipine Besylate (Norvasc) as the only anti-hypertensive medication or one of their medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of composite cardiovascular and cerebrovascular endpoints
Measured: 2 years
quality of blood pressure control
Measured: 2 years
Secondary outcomes (3)
incidence of adverse reaction
Measured: 2 years
cost-effectiveness analysis
Measured: 2 years
Explore the optimal combination of drugs for the treatment of hypertension by Levamlodipine Maleate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary HypertensionStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China, Southern Medical University, China, CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Yong Huo, Peking University First Hospital
- Investigators
- Yong Huo, MD, Principal investigator, Department of Cardiology, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844570
- Sponsor's protocol ID
- LEADER
- Acronym
- LEADER
- Status last verified
- Apr 2013
- First submitted
- 28 Apr 2013
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ma W, Sun N, Duan C, Zhao L, Hua Q, Sun Y, Dang A, Gao P, Qu P, Cui W, Zhao L, Dong Y, Cui L, Qi X, Jiang Y, Xie J, Li J, Wu G, Du X, Huo Y, Chen P; for LEADER Study Group. Effectiveness of Levoamlodipine Maleate for Hypertension Compared with Amlodipine Besylate: a Pragmatic Comparative Effectiveness Study. Cardiovasc Drugs Ther. 2021 Feb;35(1):41-50. doi: 10.1007/s10557-020-07054-1. Epub 2020 Sep 11.
PubMed 32915349
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levamlodipine Maleate (Xuanning) or Amlodipine Besylate (Norvasc) for Treatment of Hypertension: A Comparative Effectiveness Research
- ClinicalTrials.gov ID
- NCT01844570
- Acronym / sponsor ID
- LEADER / LEADER
- Conditions
- Primary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China, Southern Medical University, China, CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 1 May 2013 (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 determine whether the effectiveness of levamlodipine maleate (xuanning) is noninferior to amlodipine besylate (Norvasc) in treatment of hypertension in a Chinese primary hypertension population.
Detailed description
It is a multicenter, prospective cohort study with large sample size. It is to evaluate the effect on the incidence of cardiovascular and cerebrovascular endpoint events and blood pressure control in hypertensive patients who use Levamlodipine Maleate (Xuanning) or amlodipine besylate(Norvasc).Xuanning group and Norvasc group will recruit 5000 patients respectively. Each site will recruit patients in chronological order；patients who participate will finish the two-year follow up(1,2,3,6,12,18,24 months after recruitment) and relevant data will be recorded. Baseline data will be analyzed to evaluate the equilibrium between two or more groups (such as the number of options). Logistic regression and propensity scores (PS) would be used to match major indicators of effectiveness and safety indicators using matching method baseline data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levamlodipine Maleate (Xuanning) | – | –Primary hypertensive patients who take Levamlodipine Maleate (Xuanning) as the only anti-hypertensive medication or one of their medications |
| Amlodipine Besylate (Norvasc) | – | –Primary hypertensive patients who take Amlodipine Besylate (Norvasc) as the only anti-hypertensive medication or one of their medications |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 eligible sites(including primary care clinic and tertiary hospitals) over the country will participate. Each center will collect patients who fit the recruitment standard in chronological order.
Key inclusion criteria (4 listed)
- systolic pressure ≥140mmHg or diastolic pressure ≥90mmHg or receiving antihypertensive drug treatment
- Patient himself/herself or his/her family member has already signed the informed consent form
- Patient is fit for use of Levamlodipine Maleate or amlodipine besylate
- Age≥45
Key exclusion criteria (4 listed)
- patient with secondary hypertension
- patients who has suffered from myocardial infarction or stroke within the latest 3 months
- patients who has obvious intelligence、hearing and limb's activity disability
- Patients with severe disease, with a life expectancy of less than two years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of composite cardiovascular and cerebrovascular endpoints
Time frame: 2 years
quality of blood pressure control
Time frame: 2 years
3 secondary outcomes
incidence of adverse reaction
Time frame: 2 years
cost-effectiveness analysis
Time frame: 2 years
Explore the optimal combination of drugs for the treatment of hypertension by Levamlodipine Maleate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
- Derived from this study: PubMed 32915349Ma W, Sun N, Duan C, Zhao L, Hua Q, Sun Y, Dang A, Gao P, Qu P, Cui W, Zhao L, Dong Y, Cui L, Qi X, Jiang Y, Xie J, Li J, Wu G, Du X, Huo Y, Chen P; for LEADER Study Group. Effectiveness of Levoamlodipine Maleate for Hypertension Compared with Amlodipine Besylate: a Pragmatic Comparative Effectiveness Study. Cardiovasc Drugs Ther. 2021 Feb;35(1):41-50. doi: 10.1007/s10557-020-07054-1. Epub 2020 Sep 11.
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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.
Yong Huo, MD principal investigator
Department of Cardiology, Peking University First Hospital
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 Primary Hypertension, run by Peking University First Hospital 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 May 2013. 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?
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?
incidence of composite cardiovascular and cerebrovascular endpoints (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01844570, which also lists 1 linked publication.
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 May 2013.