Effect of Atorvastatin and Lifestyle Intervention on Prog... | NCT00723320

Studies
Effect of Atorvastatin and Lifestyle Intervention on Progression of Pre-Clinical Atherosclerosis

NCT00723320

Sponsor

Ministry of Science and Technology of the People´s Republic of China

Status

Unknown status

Last Update Posted

Aug 25, 2008Estimated

Enrollment

1,200Estimated

Phase

Not Applicable

Conditions

Atherosclerosis

Interventions

Atorvastatin
Aggressive lifestyle intervention

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

Jul 2008

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

Feb 2008

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Jul 21, 2008

First Submission Date that Met QC Criteria

Jul 24, 2008

First Posted Date

Jul 28, 2008Estimated

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

Aug 22, 2008

Last Update Posted Date

Aug 25, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Ministry of Science and Technology of the People´s Republic of ChinaOTHER_GOV

Collaborators

Name	Class
Peking University First Hospital	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 this study is to determine whether atorvastatin, aggressive lifestyle intervention, and their interaction are effective in delaying the progress of pre-clinical atherosclerosis.

Detailed Description

Primary prevention of atherosclerotic disease remains a big challenge. Currently, it is not clear how to treat those subjects with evidence of pre-clinical atherosclerosis but without obvious conventional risk factors. This randomized, placebo controlled, double blind study is to evaluate the effect of Atorvastatin 10 mg daily, therapeutic lifestyle change, and their combination, on the progression of CIMT in those with higher baseline CIMT value but are not belong to 'high risk' category, according to the conventional risk factors.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
P+N	No Intervention	placebo without lifestyle intervention
D+N	Experimental	Atorvastatin 10mg/d	Drug: Atorvastatin
P+A	Experimental	lifestyle intervention without Atorvastatin	Behavioral: Aggressive lifestyle intervention
D+A	Experimental	lifestyle intervention and Atorvastatin 10mg/d	Drug: Atorvastatin Behavioral: Aggressive lifestyle intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atorvastatin	Drug	atorvastatin 10mg/d	D+A D+N
Aggressive lifestyle intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The progress of CIMT		2 years

Secondary Outcomes

Measure	Description	Time Frame
The progress of ABI		2 years
The progress of PWV		2 years
Occurrence of atherosclerotic disease

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CIMT is not less than 0.9 mm
without Clinical diagnosis of atherosclerotic disease
without Diabetes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianping Li	Contact	86-10-66551122	5262

Overall Officials

Name	Affiliation	Role
Jianping Li	Peking University First Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University First Hospital	Recruiting	Beijing	Beijing Municipality	100034	China

Condition Browse Module

MeSH Terms

ID	Term
D050197	Atherosclerosis

Ancestor Terms

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
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