Effects and Underlying Mechanism of Lipid Lowering Interv... | NCT02254824

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

NCT02254824

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Unknown status

Last Update Posted

Oct 2, 2014Estimated

Enrollment

300Estimated

Phase

Phase 4

Conditions

Hypertension

Interventions

Xuezhikang
Atorvastatin
Lifestyle modification

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Oct 2015Estimated

Completion Date

Oct 2016Estimated

First Submitted Date

Apr 17, 2014

First Submission Date that Met QC Criteria

Sep 29, 2014

First Posted Date

Oct 2, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2014

Last Update Posted Date

Oct 2, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Aimin Dang, Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences, Fuwai HospitalPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical Sciences, Fuwai HospitalOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal-dose statin	Active Comparator	Lifestyle modification with Normal-dose statin	Drug: Atorvastatin Behavioral: Lifestyle modification
Lifestyle modification + Xuezhikang	Active Comparator	Lifestyle changes with Xuezhikang	Drug: Xuezhikang Behavioral: Lifestyle modification
Lifestyle modification	Active Comparator	Lifestyle modification	Behavioral: Lifestyle modification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Xuezhikang	Drug	Xuezhikang	Lifestyle modification + Xuezhikang
Atorvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary endpoint is the Flow Mediated Dilatation (FMD)		1 year

Secondary Outcomes

Measure	Description	Time Frame
the carotid - femoral Pulse Wave Velocity (cf-PWV),		1 year
inflammatory markers		1 year
lipid profiles

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aimin - Dang, Doctor	Contact	0086-10-88398155		amdang@fuwaihospital.org

Overall Officials

Name	Affiliation	Role
Aimin Dang, Doctor	Fuwai Hospital & Cardiovascular Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fuwai Hospital	Recruiting	Beijing	Beijing Municipality	100037	China

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C496822	xuezhikang
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided