Observational Usage Study of Statins in Primary Care in F... | NCT00680082

Studies
Observational Usage Study of Statins in Primary Care in France

NCT00680082

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 2, 2010Estimated

Enrollment

2,100Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

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

Dec 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

May 15, 2008

First Submission Date that Met QC Criteria

May 16, 2008

First Posted Date

May 19, 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

Dec 1, 2010

Last Update Posted Date

Dec 2, 2010Estimated

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

To describe the way statins are used in France in primary care, that is to determine patients profile (particularly CV risk factors), to determine the way statins are initiated by general practitioners, to evaluate aftercare and to assess patients treated by rosuvastatin

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients to whom a statin was initiated or switched between 3 and 6 months before consultation

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients to whom a statin was initiated or switched between 3 and 6 months before consultation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients recruited by a GP, community sample

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francois Morand	Cegedim Strategic Data - Boulogne Billancourt - France	Principal Investigator
Jean Dallongeville	Institut Pasteur - Inserm U744 - Lille -France	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Hefei	Anhui		China
Research Site