Complex DyslipidemiaNCT02382159
A Observational Study to Evaluate Lipid-lowering Drug Its Effect on Parameters in Dyslipidemia of Type 2 Diabetes.
An observational study of Complex Dyslipidemia, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
1. Target disease: Patients with combined dyslipidemia accompanied by type 2 diabetes who has done exogenous visit or hospitalization from Jan 2010 to June 2014. 2. Study objective: 1. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Complex Dyslipidemia
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. 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. 2. 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 3. 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.
Who may be able to join
- 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.
Who cannot join
- 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
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- Patients treated by Steroids.
- Pregnant or lactating woman
- Patients who are judged as not suitable for this study by Investigator.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea(Bucheon St. Mary's Hospital)
Bucheon-si
About this study
Official title: Observational, Retrospective, Multi-center Study for Therapeutic Practice Pattern of Lipid-lowering Drug and Its Effect on Parameters in Dyslipidemia of Type 2 Diabetes.
- 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:
- 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.
- 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.
- If the drug dosage and pharmacotherapy have been changed, Identifying the lipid parameter variation when treating patients by altered drugs for 3±1 months,
- Conditions
- Complex Dyslipidemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the Lipid parameter pattern patients who are treated by lipid-lowering drug.
Increasing LDL-C + Triglyceride(TG)Decreasing HDL-C + Increasing TG
Measured: Over 3±1 months
Secondary outcomes (2)
The reason why changed drug dosage and pharmacotherapy after patients taken lipid-lowering drug.
Increasing LDL-C + TG Decreasing HDL-C + Increasing TG
Measured: Over 3±1 months
Variation for lipid parameter when the patients who are treated for 3±1 months by lipid-lowering drug.
Increasing LDL-C + TGDecreasing HDL-C + Increasing TG
Measured: Over 3±1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startOct 2010
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung-Rae Kim, M.D, Principal investigator, Catholic University of Korea (Bucheon St.Mary's Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382159
- Sponsor's protocol ID
- YYP-OS-001
- Status last verified
- Jul 2015
- First submitted
- 25 Feb 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Retrospective, Multi-center Study for Therapeutic Practice Pattern of Lipid-lowering Drug and Its Effect on Parameters in Dyslipidemia of Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT02382159
- Acronym / sponsor ID
- YYP-OS-001
- Conditions
- Complex Dyslipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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:
- 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.
- 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.
- If the drug dosage and pharmacotherapy have been changed, Identifying the lipid parameter variation when treating patients by altered drugs for 3±1 months,
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. 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. 2. 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 3. 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Variation of the Lipid parameter pattern patients who are treated by lipid-lowering drug.
Time frame: Over 3±1 months
Increasing LDL-C + Triglyceride(TG)Decreasing HDL-C + Increasing TG
2 secondary outcomes
The reason why changed drug dosage and pharmacotherapy after patients taken lipid-lowering drug.
Time frame: Over 3±1 months
Variation for lipid parameter when the patients who are treated for 3±1 months by lipid-lowering drug.
Time frame: Over 3±1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Rae Kim, M.D principal investigator
Catholic University of Korea (Bucheon St.Mary's Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Dyslipidemia, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the Lipid parameter pattern patients who are treated by lipid-lowering drug. (time frame: Over 3±1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2015.