- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02254824
Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients
September 29, 2014 updated by: Aimin Dang, Chinese Academy of Medical Sciences, Fuwai Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
300
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aimin - Dang, Doctor
- Phone Number: 0086-10-88398155
- Email: amdang@fuwaihospital.org
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100037
- Recruiting
- Fuwai Hospital
-
Principal Investigator:
- Aimin Dang, Doctor
-
Contact:
- Naqiang Lv, Doctor
- Phone Number: 0086-10-13466500331
- Email: lvnaqiang@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients must meet the hypertension with low or moderate cardiovascular risk following 2010 Guidelines for prevention and treatment of hypertension in China
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Normal-dose statin
Lifestyle modification with Normal-dose statin
|
Atorvastatin
Lifestyle modification
|
Active Comparator: Lifestyle modification + Xuezhikang
Lifestyle changes with Xuezhikang
|
Lifestyle modification
Xuezhikang
|
Active Comparator: Lifestyle modification
|
Lifestyle modification
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint is the Flow Mediated Dilatation (FMD)
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the carotid - femoral Pulse Wave Velocity (cf-PWV),
Time Frame: 1 year
|
1 year
|
inflammatory markers
Time Frame: 1 year
|
1 year
|
lipid profiles
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Aimin Dang, Doctor, Fuwai Hospital & Cardiovascular Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Anticipated)
October 1, 2015
Study Completion (Anticipated)
October 1, 2016
Study Registration Dates
First Submitted
April 17, 2014
First Submitted That Met QC Criteria
September 29, 2014
First Posted (Estimate)
October 2, 2014
Study Record Updates
Last Update Posted (Estimate)
October 2, 2014
Last Update Submitted That Met QC Criteria
September 29, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SF2011-4003-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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