Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients
1 other identifier
interventional
300
1 country
1
Brief Summary
The purpose of EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in hypertensive patients at low/moderate cardiovascular risk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hypertension
Started Oct 2013
Typical duration for phase_4 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 17, 2014
CompletedFirst Posted
Study publicly available on registry
October 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 2, 2014
September 1, 2014
2 years
April 17, 2014
September 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint is the Flow Mediated Dilatation (FMD)
1 year
Secondary Outcomes (3)
the carotid - femoral Pulse Wave Velocity (cf-PWV),
1 year
inflammatory markers
1 year
lipid profiles
1 year
Study Arms (3)
Normal-dose statin
ACTIVE COMPARATORLifestyle modification with Normal-dose statin
Lifestyle modification + Xuezhikang
ACTIVE COMPARATORLifestyle changes with Xuezhikang
Lifestyle modification
ACTIVE COMPARATORLifestyle modification
Interventions
Lifestyle modification
Eligibility Criteria
You may qualify if:
- All patients must meet the hypertension with low or moderate cardiovascular risk following 2010 Guidelines for prevention and treatment of hypertension in China
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aimin Dang, Doctor
Fuwai Hospital & Cardiovascular Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cardiovascular Institute & Fuwai Hospital
Study Record Dates
First Submitted
April 17, 2014
First Posted
October 2, 2014
Study Start
October 1, 2013
Primary Completion
October 1, 2015
Study Completion
October 1, 2016
Last Updated
October 2, 2014
Record last verified: 2014-09