Effect of PATient Education Related to CV Risk factOrs in... | NCT00891124

Studies
Effect of PATient Education Related to CV Risk factOrs in Type 2 Diabetes Mellitus(Patrol).

NCT00891124

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Nov 3, 2009Estimated

Enrollment

4,045Actual

Phase

Not provided

Conditions

Glycemia
Hypertension
Hyperlipidemia

Interventions

Not provided

Countries

South Korea

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

Nov 2009

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

May 2009

Primary Completion Date

Not provided

Completion Date

Oct 2009Actual

First Submitted Date

Apr 28, 2009

First Submission Date that Met QC Criteria

Apr 30, 2009

First Posted Date

May 1, 2009Estimated

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

Nov 2, 2009

Last Update Posted Date

Nov 3, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study will address the proportion of achievement patients in treatment target goal on glycemic control, hypertension and hyperlipidemia according to ADA 2008 guideline, among outpatients coming to the Korean primary care nationwide.

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

4,045Actual

Label	Type	Description	Intervention Names
1		Type II DM and Hypertension and/or Hyperlipidemia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of achievement patients in treatment target goal on glycemic control, hypertension and hyperlipidemia according to ADA 2008 guideline		At baseline and Endpiont (after 2months)

Secondary Outcomes

Measure	Description	Time Frame
The treatment goal of risk factors is based on ADA guideline.		At baseline and Endpiont (after 2months)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who had been diagnosed with type II diabetes mellitus
Patients with hypertension and / or hyperlipidemia
Patients who had agreed to Informed

Exclusion Criteria:

Patients who had been diagnosed with type I diabetes mellitus
Patients with neither hypertension and hyperlipidemia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Type II DM and Hypertension and/or Hyperlipidemia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joonwoo Bahn	ASTRAZENECA, Korea Medical Department	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Busan			South Korea
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D006949	Hyperlipidemias

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided