HypertensionPhase 4NCT02254824
Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients
A Phase 4 study testing Xuezhikang, Atorvastatin and Lifestyle modification in people with Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
The purpose of EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in hypertensive patients at low/moderate cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Xuezhikang, Atorvastatin and Lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Oct 2016
- 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
- All patients must meet the hypertension with low or moderate cardiovascular risk following 2010 Guidelines for prevention and treatment of hypertension in China
Who cannot join
- Secondary Hypertension
- Women who are pregnant or lactating
- History of mental instability, or major psychiatric illness not adequately controlled and stable on therapy
- Type 2 Diabetes
- Active liver disease or impaired liver function tests
- Impaired renal function
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- Uncontrolled cardiac arrhythmia
- Patient who is unable to give informed consent
- Any condition or situation, which in the opinion of the investigator, might pose a risk to the patient or confound the results of the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Naqiang Lv, Doctor, 0086-10-13466500331, lvnaqiang@gmail.com
Aimin Dang, Doctor
About this study
Official title: Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients (EMINENT Study)
The purpose of EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in hypertensive patients at low/moderate cardiovascular risk.
Read the detailed description
EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin on vascular function protection in hypertensive patients at low/moderate cardiovascular risk.
- Conditions
- Hypertension
- Being tested
- Xuezhikang, Atorvastatin, Lifestyle modification
- Keywords
- Xuezhikang, atorvastatin
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XuezhikangDrug
Xuezhikang
AtorvastatinDrug
Atorvastatin
Lifestyle modificationBehavioural
Lifestyle modification
| Study group | Role | What they receive |
|---|---|---|
| Normal-dose statin | Active comparator | Lifestyle modification with Normal-dose statin Receives: Drug: Atorvastatin; Behavioral: Lifestyle modification |
| Lifestyle modification + Xuezhikang | Active comparator | Lifestyle changes with Xuezhikang Receives: Drug: Xuezhikang; Behavioral: Lifestyle modification |
| Lifestyle modification | Active comparator | Lifestyle modification Receives: Behavioral: Lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the Flow Mediated Dilatation (FMD)
Measured: 1 year
Secondary outcomes (3)
the carotid - femoral Pulse Wave Velocity (cf-PWV),
Measured: 1 year
inflammatory markers
Measured: 1 year
lipid profiles
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2015 (estimated)
- Study completionOct 2016 (estimated)
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.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Peking Union Medical College Hospital, Beijing Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Aimin Dang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Aimin Dang, Doctor, Principal investigator, Fuwai Hospital & Cardiovascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254824
- Sponsor's protocol ID
- SF2011-4003-04
- Status last verified
- Sep 2014
- First submitted
- 17 Apr 2014
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients (EMINENT Study)
- ClinicalTrials.gov ID
- NCT02254824
- Acronym / sponsor ID
- SF2011-4003-04
- Conditions
- Hypertension
- Keywords
- Xuezhikang, atorvastatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Peking Union Medical College Hospital, Beijing Hospital of Traditional Chinese Medicine
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 2 Oct 2014 (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 EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in hypertensive patients at low/moderate cardiovascular risk.
Detailed description
EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin on vascular function protection in hypertensive patients at low/moderate cardiovascular risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal-dose statin | Active comparator | Drug: Atorvastatin, Behavioral: Lifestyle modificationLifestyle modification with Normal-dose statin |
| Lifestyle modification + Xuezhikang | Active comparator | Drug: Xuezhikang, Behavioral: Lifestyle modificationLifestyle changes with Xuezhikang |
| Lifestyle modification | Active comparator | Behavioral: Lifestyle modificationLifestyle modification |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients must meet the hypertension with low or moderate cardiovascular risk following 2010 Guidelines for prevention and treatment of hypertension in China
Key exclusion criteria (9 listed)
- Secondary Hypertension
- Women who are pregnant or lactating
- History of mental instability, or major psychiatric illness not adequately controlled and stable on therapy
- Type 2 Diabetes
- Active liver disease or impaired liver function tests
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 |
|---|---|---|
| XuezhikangXuezhikang | Drug | Lifestyle modification + Xuezhikang |
| AtorvastatinAtorvastatin | Drug | Normal-dose statin |
| Lifestyle modificationLifestyle modification | Behavioural | Lifestyle modification, Lifestyle modification + Xuezhikang, Normal-dose statin |
Primary outcome
The primary endpoint is the Flow Mediated Dilatation (FMD)
Time frame: 1 year
3 secondary outcomes
the carotid - femoral Pulse Wave Velocity (cf-PWV),
Time frame: 1 year
inflammatory markers
Time frame: 1 year
lipid profiles
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
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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.
Aimin Dang, Doctor principal investigator
Fuwai Hospital & Cardiovascular Institute
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 Xuezhikang, Atorvastatin and Lifestyle modification in people with Hypertension, run by Chinese Academy of Medical Sciences, Fuwai 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 1 inclusion and 9 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 2 Oct 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aimin - Dang, Doctor (0086-10-88398155, amdang@fuwaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the Flow Mediated Dilatation (FMD) (time frame: 1 year). 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 2 Oct 2014.