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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital
        • Principal Investigator:
          • Aimin Dang, Doctor
        • Contact:

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
Drug: Atorvastatin
Atorvastatin
Behavioral: Lifestyle modification
Lifestyle modification
Active Comparator: Lifestyle modification + Xuezhikang
Lifestyle changes with Xuezhikang
Behavioral: Lifestyle modification
Lifestyle modification
Drug: Xuezhikang
Xuezhikang
Active Comparator: Lifestyle modification
Behavioral: 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.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborators

Peking University First Hospital
Peking Union Medical College Hospital
Beijing Hospital of Traditional Chinese Medicine

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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