Epidemiologic Study to Evaluate the Proportion of Cardiov... | NCT01362283

Studies
Epidemiologic Study to Evaluate the Proportion of Cardiovascular Disease Risk Factors in Korean Hypertensive Patients

NCT01362283

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Dec 1, 2016Estimated

Enrollment

3,109Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Blood Sampling

Countries

Not provided

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 2016

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

Aug 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

May 5, 2011

First Submission Date that Met QC Criteria

May 26, 2011

First Posted Date

May 30, 2011Estimated

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 30, 2016

Last Update Posted Date

Dec 1, 2016Estimated

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

The purpose of this study is investigating the proportion of Cardiovascular disease risk factors of hypertensive patients.

Detailed Description

Primary endpoint: To evaluate the Proportion of patients with Cardiovascular disease high risk factors

Secondary endpoint: To evaluate the Proportion of patients with Cardiovascular disease risk factors, To evaluate the Proportion of patients with Cardiovascular disease, To evaluate Target blood pressure achievement rate according to the proportion of Cardiovascular disease risks

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

3,109Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypertension		Subject who meet eligible criteria	Other: Blood Sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood Sampling	Other	Blood sampling for Fasting Plasma Glucose, Hemoglobin A1C, Cholesterols, Blood Urea Nitrogen, Creatinine	Hypertension

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients with cardiovascular disease high risk factors	Between patients with essential hypertension	6years, average duration of hypertension

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients with Cardiovascular disease risk factors	Between patients with essential hypertension	6years, average duration of hypertension
Proportion of patients with Cardiovascular disease

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Essential hypertensive patient no less than 18 yeas old
Patient who gave informed consent form

Exclusion Criteria:

Patient was diagnosed as secondary hypertension
Patient who have white-coat hypertension

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

Korea, Diagnosed hypertensive patient

Sampling Method

Probability Sample

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

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
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided