NCT03217409

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

August 10, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2019

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

July 12, 2017

Last Update Submit

September 19, 2019

Conditions

Diabetes Mellitus and Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Low density lipoprotein cholesterol (LDL-C) (%)

    The rate of change(%) of LDL-C at Week 8 compared to the baseline

    baseline, Week 8

Secondary Outcomes (5)

  • Low density lipoprotein cholesterol (LDL-C) (100mg/dL)

    baseline, Week 8

  • HbA1C, Glycated albumin, Homeostasis model assessment Insulin resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß)

    baseline, Week 8

  • LDL-C, Non HDL-C, HDL-C, Triglyceride(TG), Total cholesterol(TC), Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C)

    baseline, Week 8

  • Thiobarbituric acid reactive substances(TBARs)

    baseline, Week 8

  • Fibroblast Growth Factor 21

    baseline, Week 8

Study Arms (2)

Rosuvastatin+Ezetimibe

EXPERIMENTAL

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

Drug: Rosuvastatin+Ezetimibe

Rosuvastatin

ACTIVE COMPARATOR

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

Drug: Rosuvastatin

Interventions

Rosuvastatin+EzetimibeDRUG

Rosuvastatin 5mg+Ezetimibe 10mg

Also known as: Rosuvamibe ® 10/5mg
Rosuvastatin+Ezetimibe
RosuvastatinDRUG

Rosuvastatin 5Mg Tablet

Also known as: Monorova ® 5mg
Rosuvastatin

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

Location

Soon Chun Hyang University Hospital Gumi

Gumi, South Korea

Location

Soon Chun Hyang University Hospital Bucheon

Gyeonggi-do, South Korea

Location

Soon Chun Hyang University Hospital Seoul

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes MellitusHypercholesterolemia

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 14, 2017

Study Start

August 10, 2017

Primary Completion

April 3, 2019

Study Completion

May 23, 2019

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(4)