A Study to Compare Rosuvastatin/Ezetimibe and Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia

NCT ID: NCT03217409

Last Updated: 2019-09-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-10

Study Completion Date

2019-05-23

Brief Summary

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A Study to Compare Rosuvastatin/Ezetimibe Combination and Monotherapy in Patients with Diabetes Mellitus and Hypercholesterolemia.

Detailed Description

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This trial is conducted to compare the efficacy and safety between Rosuvastatin/Ezetimibe combination and Rosuvastatin monotherapy in patients with Diabetes Mellitus and Hypercholesterolemia for 8 weeks.

Conditions

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Diabetes Mellitus and Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rosuvastatin+Ezetimibe

Rosuvastatin 5mg+Ezetimibe 10mg Rosuvamibe ® Tablet, 1T, Once a day/8week

Group Type EXPERIMENTAL

Rosuvastatin+Ezetimibe

Intervention Type DRUG

Rosuvastatin 5mg+Ezetimibe 10mg

Rosuvastatin

Rosuvastatin 5mg Monorova ® Tablet, 1T, Once a day/8week

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

Rosuvastatin 5Mg Tablet

Interventions

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Rosuvastatin+Ezetimibe

Rosuvastatin 5mg+Ezetimibe 10mg

Intervention Type DRUG

Rosuvastatin

Rosuvastatin 5Mg Tablet

Intervention Type DRUG

Other Intervention Names

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Rosuvamibe ® 10/5mg Monorova ® 5mg

Eligibility Criteria

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Inclusion Criteria

* Subjects ≥ 19 or ≤ 75 years of age
* Subjects undergoing treatment for type 2 diabetes
* Subjects undergoing treatment of statin for hypercholesterolemia
* Fasting LDL-C ≤ 250mg/dL at the screening visit
* Fasting LDL-C ≥70mg/dL or ≤ 160mg/dL at the randomization visit
* Fasting TG\<500mg/dL

Exclusion Criteria

* Subjects with hypersensitivity reaction to Statin and Ezetimibe
* Subjects with severe kidney disease
* Subjects with HIV positive result at the screening
* Pregnant or breast-feeding subjects
* Subjects with taking any medication affecting level of LDL (Fenofibrate, Omega 3 fatty aicd etc.)
* Insulin-treated Subjects
* Other exclusions applied
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linical Korea

INDUSTRY

Sponsor Role collaborator

Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Soon Chun Hyang University Hospital Cheonan

Cheonan, , South Korea

Site Status

Soon Chun Hyang University Hospital Gumi

Gumi, , South Korea

Site Status

Soon Chun Hyang University Hospital Bucheon

Gyeonggi-do, , South Korea

Site Status

Soon Chun Hyang University Hospital Seoul

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YMC022

Identifier Type: -

Identifier Source: org_study_id

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