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An Observational Study Investigating the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes | Clinical Trials | Clareo Health

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An Observational Study Investigating the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes

A Multi-center, Prospective Observational Study to Investigate the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes

NCT05107063•Daiichi Sankyo

View on ClinicalTrials.gov

Summary

This study investigated the effectiveness of pravastatin on renal function in Korean dyslipidemic patients with Type 2 diabetes.

Detailed Description

This survey study investigated the effect of routine initiation single dose of pravastatin (10 mg, 20 mg, or 40 mg) on renal function in Korean dyslipidemic patients with Type 2 diabetes. The study also examined the effect of pravastatin on lipid profiles, glucose metabolism, and safety.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with Type 2 diabetes (currently using an antidiabetic drug or satisfying diagnostic criteria of diabetes as defined by American Diabetes Association)
•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 who had administered pravastatin prior to study participation
•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

Locations (47)

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

Key Dates

Start Date

January 20, 2016

Primary Completion Date

April 19, 2018

Completion Date

April 19, 2018

Last Updated

November 4, 2021

Enrollment

2,972

ACTUAL participants

Conditions

Dyslipidemia Associated With Type II Diabetes Mellitus

Interventions

Pravastatin

DRUG

Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools

NCT05563090

Diabete MellitusPre-diabetes+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 4, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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