Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients

NCT ID: NCT02254824

Last Updated: 2014-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-10-31

Brief Summary

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The purpose of EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in hypertensive patients at low/moderate cardiovascular risk.

Detailed Description

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EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin on vascular function protection in hypertensive patients at low/moderate cardiovascular risk.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal-dose statin

Lifestyle modification with Normal-dose statin

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Atorvastatin

Lifestyle modification

Intervention Type BEHAVIORAL

Lifestyle modification

Lifestyle modification + Xuezhikang

Lifestyle changes with Xuezhikang

Group Type ACTIVE_COMPARATOR

Xuezhikang

Intervention Type DRUG

Xuezhikang

Lifestyle modification

Intervention Type BEHAVIORAL

Lifestyle modification

Lifestyle modification

Lifestyle modification

Group Type ACTIVE_COMPARATOR

Lifestyle modification

Intervention Type BEHAVIORAL

Lifestyle modification

Interventions

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Xuezhikang

Xuezhikang

Intervention Type DRUG

Atorvastatin

Atorvastatin

Intervention Type DRUG

Lifestyle modification

Lifestyle modification

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Beijing Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Aimin Dang

Cardiovascular Institute & Fuwai Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aimin Dang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital & Cardiovascular Institute

Locations

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Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Aimin - Dang, Doctor

Role: CONTACT

0086-10-88398155

Facility Contacts

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Naqiang Lv, Doctor

Role: primary

0086-10-13466500331

Other Identifiers

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SF2011-4003-04

Identifier Type: -

Identifier Source: org_study_id

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