A Observational Study to Evaluate Lipid-lowering Drug Its... | NCT02382159

Studies
A Observational Study to Evaluate Lipid-lowering Drug Its Effect on Parameters in Dyslipidemia of Type 2 Diabetes.

NCT02382159

Sponsor

Yooyoung Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jul 17, 2015Estimated

Enrollment

1,000Actual

Phase

Not provided

Conditions

Complex Dyslipidemia

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

Jul 2015

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

Oct 2010

Primary Completion Date

Apr 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Feb 25, 2015

First Submission Date that Met QC Criteria

Mar 2, 2015

First Posted Date

Mar 6, 2015Estimated

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

Jul 15, 2015

Last Update Posted Date

Jul 17, 2015Estimated

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

Target disease: Patients with combined dyslipidemia accompanied by type 2 diabetes who has done exogenous visit or hospitalization from Jan 2010 to June 2014.
Study objective:
1. The objective of this study is to Identifying the lipid parameter variation when treating patients who have dyslipidemia of type 2 diabetes for 3±1 months.
2. After treating patients who have dyslipidemia of type 2 diabetes for 3±1 months, identifying the reason why changing method of drug dosage and pharmacotherapy.
3. If the drug dosage and pharmacotherapy have been changed, Identifying the lipid parameter variation when treating patients by altered drugs for 3±1 months,

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

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

1,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Variation of the Lipid parameter pattern patients who are treated by lipid-lowering drug.	Increasing LDL-C + Triglyceride(TG)Decreasing HDL-C + Increasing TG	Over 3±1 months

Secondary Outcomes

Measure	Description	Time Frame
The reason why changed drug dosage and pharmacotherapy after patients taken lipid-lowering drug.	Increasing LDL-C + TG Decreasing HDL-C + Increasing TG	Over 3±1 months
Variation for lipid parameter when the patients who are treated for 3±1 months by lipid-lowering drug.

Other Outcomes

Measure	Description	Time Frame
Setting the sub-group by the result of lipid parameter	Decreasing HDL-C: HDL-C≤40mg/dL(Man), ≤50mg/dL(Woman) Non-decreasing HDL-C: HDL-C≤40mg/dL(Man), >50mg/dL(Woman)	Basis on the Base-line

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Among the patients, who has been hospitalized or visited the Outpatient Department OPD, who has dyslipidemia of type 2 diabetes.

Patients have the result of lipid parameter test at baseline and after lipid-lowering drug for at least 3 months.
Patients who have the result of lipid paraneter test (LDL-C ≥100mg/dL, TG ≥150mg/dL) at baseline.
Patients who have no received lipid lowering drug fr at least 2 months prior to the baseline.
Patients' age were > 20 years and <75 year.

Exclusion Criteria:

Patients who ahs HbA1c≥9%
Patients who have no the result of lipid parameter test at baseline and at baseline and after lipid-lowering drug for at least 3 months
Patients who have history of drug discontinuation by incresed liver enzyme or rhabdomyolysis.
Patients received lipid-lowering drug and TZD(Thiazolidinediones) in study period
Renal abnormality
Alcoholism or Alcohol abuse
Patients treated by Steroids.
Pregnant or lactating woman
Patients who are judged as not suitable for this study by Investigator.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Base-line (The starting time of treating lipid-lowering drug within 3 months period of 2010 ~ 2013 years)
- Background of Patients: Basic information(Height, Weight), Smoking, Drinking and other related illness.
- Hypoglucemic agent, Diabetes test(Fasting blood glucose, GL test, Glycated Hemoglobin)
- At the time of Starting the treating lipid-lowering drug, total Cholesterol, TG, LDL-C, HDL-C checked before treating lipid-lowering drug.
After 3±1 months from base-line
- Hypoglycemic agent, Diabetes test
- Total Cholesterol, TG, LDL-C at the point of 3±1 months from treating changed lipid-lowering drug, and the reason of drug dosage and pharmacotherapy
After 3±1 months from treating by changed lipid-lowering drug
- Hypoglycemic agent, Diabetes test
- Total Cholesterol, TG, LDL-C, HDL-C at the point of 3±1 months from treating changed lipid-lowering drug.

Sampling Method

Probability Sample