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NCT Number: NCT04829149

Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration in Patients With Dyslipidemia in Korea

A Cohort Study for Comparison of Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration and Statin Prescription Patterns in Patients With Dyslipidemia in Korea.

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanmi Pharmaceutical Company Limited

Seoul, 05545, South Korea

About this study

The main objective of this study is to evaluate the effect of reducing LDL-C levels after 12 months of administration of Statin Monotherapy or Rosuzet Tab.(Rosuvastatin/Ezetimibe) in patients with dyslipidemia in Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age≥19
  • Subject who is taking or is scheduled to take Statins therapy or Rosuzet Tab.
  • Not diagnosed with diabetes
  • Subject who can written informed consent voluntarily
  • Subject can continue to participate for 12 months on Study

Exclusion criteria

  • Patients for whom use of Rosuzet Tab. and Statin therapy is prohibited (e.g. patient who are hypersensitive to the main or compositional component of this drug, patient with active liver disease, patient with severe renal failure, patient using combinations with cyclosporin)
  • A pregnant or nursing woman

Treatment and study plan

Observational

Other

Statin therapy group and Rosuzet tablet group

Primary outcomes

  1. Lipid profiles

    Time frame: 12 months

    LDL-C percentage of change in Statin therapy group and Rosuzet group from baseline

Secondary outcomes

  1. Lipid profiles

    Time frame: 6 months

    LDL-C percentage of change in Statin therapy group and Rosuzet group from baseline

  2. Lipid profiles

    Time frame: 6, 12 months

    Triglyceride, HDL-C, Total Cholesterol percentage of change in Statin therapy group and Rosuzet group from baseline

  3. Occurrence and aspect of new onset diabetes and adverse events

    Time frame: 12 months

    Occurrence and aspect of new onset diabetes and adverse events in Statin therapy group and Rosuzet group during the study period

  4. Prescription rate

    Time frame: 12 months

    Prescription rate of Statin therapy group and Rosuzet group during the study period

  5. Reason for medication change

    Time frame: 12 months

    Evaluation of Rate on reason for medication change in Statin therapy group and Rosuzet group during the study period

  6. Medication compliance

    Time frame: 12 months

    MPR(medication possession ratio) of Statin therapy group and Rosuzet group during the study period

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Cohort Study for Comparison of Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration and Statin Prescription Patterns in Patients With Dyslipidemia in Korea.

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 2, 2021
Registry last updated
Apr 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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