An Observational Study Investigating the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes
NCT ID: NCT05107063
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2972 participants
OBSERVATIONAL
2016-01-20
2018-04-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Dyslipidemic participants with Type 2 diabetes
Dyslipidemic participants with Type 2 diabetes who received a routine initiation dose of pravastatin 10 mg, 20 mg or 40 mg single dose once daily and maintained a low cholesterol diet throughout the study period.
Pravastatin
Routine initiation dose was 10 mg, 20 mg or 40 mg single dose once daily. Depending on patient response, dose could have been increased up to 40 mg. Maintenance dose was 10-40 mg once daily.
Interventions
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Pravastatin
Routine initiation dose was 10 mg, 20 mg or 40 mg single dose once daily. Depending on patient response, dose could have been increased up to 40 mg. Maintenance dose was 10-40 mg once daily.
Eligibility Criteria
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Inclusion Criteria
* Participants with dyslipidemia (currently using an antidyslipidemic drug or satisfying the Health Insurance Review \& Assessment Service insurance coverage treatment criteria\*) for whom drug treatment with pravastatin is confirmed
* Participants determined to be eligible as subjects at the discretion of the investigator
* Participants who voluntarily provided written consent using the Informed Consent Form on Use of Information
Exclusion Criteria
* Participants with hypersensitivity to the investigational product or its history
* Participants with an active liver disease or persistent elevation of transaminase with an unknown cause
* Pregnant woman or women with childbearing potential, breastfeeding mothers
* Children
* Participants with severe hepatic or renal insufficiency
* Participants with myopathy
* Participants with cholestasis
* Participants with hypercholesterolemia due to hyperalphalipoproteinemia accompanied by HDL cholesterol elevation
* Participants with a genetic problem such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
18 Years
ALL
No
Sponsors
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Daiichi Sankyo Korea Co., Ltd.
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Korea University Ansan Hospital
Ansan, , South Korea
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, , South Korea
Yeongnam University Medical Center
Busan, , South Korea
Inje University Busan Paik Hospital - Site 23
Busan, , South Korea
Inje University Busan Paik Hospital - Site 26
Busan, , South Korea
Bong Seng Memorial Hospital
Busan, , South Korea
Pusan National University Hospital - Site 43
Busan, , South Korea
Pusan National University Hospital - Site 49
Busan, , South Korea
Kosin University Gospel Hospital
Busan, , South Korea
Changwon Fatima Hospital
Changwon, , South Korea
Soon Chun Hyang University Cheonan Hospital
Cheonan, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Eulji University DaeJeon Medical Center
Daejeon, , South Korea
Konyang University Hospital
Daejeon, , South Korea
GangNeung Asan Hospital
Gangneung, , South Korea
Dongguk University Ilsan Hospital
Goyang, , South Korea
Inje University Ilsan Paik Hospital
Goyang, , South Korea
National Health Insurance Service Ilsan Hospital
Goyang, , South Korea
Myongji Hospital
Goyang, , South Korea
Chosun University Hospital
Gwangju, , South Korea
Gwangju Veterans Hospital
Gwangju, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Bundang CHA General Hospital
Seongnam, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
HANIL General Hospital
Seoul, , South Korea
Korea Cancer Center Hospital
Seoul, , South Korea
Eulji University Medical Center - Site 20
Seoul, , South Korea
Eulji University Medical Center - Site 52
Seoul, , South Korea
Seoul Medical Center
Seoul, , South Korea
The Catholic University of Korea, St. Paul's Hospital
Seoul, , South Korea
Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Soon Chun Hyang University Seoul Hospital
Seoul, , South Korea
Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
Kangdong Sacred Heart Hospital
Seoul, , South Korea
VHS Medical Center
Seoul, , South Korea
Yonsei University Health System, Gangnam Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Chung-Ang Univerisity Hospital
Seoul, , South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, , South Korea
St. Carollo General Hospital
Suncheon, , South Korea
The Catholic University of Korea, St. Vincent's Hospital - Site 45
Suwon, , South Korea
The Catholic University of Korea, St. Vincent's Hospital - Site 50
Suwon, , South Korea
Ajou University Hospital - Site 04
Suwon, , South Korea
Ajou University Hospital - Site 05
Suwon, , South Korea
Dongkang Medical Center
Ulsan, , South Korea
Yonsei University, Wonju Severance Christian Hospital - Site 10
Wŏnju, , South Korea
Yonsei University, Wonju Severance Christian Hospital - Site 15
Wŏnju, , South Korea
Countries
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References
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Kim HJ, Hur KY, Lee YH, Kim JT, Lee YK, Baek KH, Choi EJ, Hwang WM, Bang KT, Lim JS, Chung YJ, Jo SR, Oh JS, Lee SH, Ko SH, Choi SH. Effect of Pravastatin on Kidney Function in Patients with Dyslipidemia and Type 2 Diabetes Mellitus: A Multicenter Prospective Observational Study. Adv Ther. 2024 Aug;41(8):3119-3137. doi: 10.1007/s12325-024-02862-5. Epub 2024 Jun 16.
Other Identifiers
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MVT-OS-15-01
Identifier Type: -
Identifier Source: org_study_id