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Trial record 24 of 74 for:    Recruiting, Not yet recruiting, Available Studies | "Hypercholesterolemia"

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

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ClinicalTrials.gov Identifier: NCT03217409
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : January 11, 2018
Sponsor:
Collaborator:
Linical Korea
Information provided by (Responsible Party):
Yuhan Corporation

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus and Hypercholesterolemia Drug: Rosuvastatin+Ezetimibe Drug: Rosuvastatin Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Clinical Trial to Compare the Efficacy and Safety Between Rosuvastatin/Ezetimibe Combination and Monotherapy of Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia
Actual Study Start Date : August 10, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : July 2018


Arm Intervention/treatment
Experimental: Rosuvastatin+Ezetimibe
Rosuvastatin 5mg+Ezetimibe 10mg Rosuvamibe ® Tablet, 1T, Once a day/8week
Drug: Rosuvastatin+Ezetimibe
Rosuvastatin 5mg+Ezetimibe 10mg
Other Name: Rosuvamibe ® 10/5mg

Active Comparator: Rosuvastatin
Rosuvastatin 5mg Monorova ® Tablet, 1T, Once a day/8week
Drug: Rosuvastatin
Rosuvastatin 5Mg Tablet
Other Name: Monorova ® 5mg




Primary Outcome Measures :
  1. Low density lipoprotein cholesterol (LDL-C) (%) [ Time Frame: baseline, Week 8 ]
    The rate of change(%) of LDL-C at Week 8 compared to the baseline


Secondary Outcome Measures :
  1. Low density lipoprotein cholesterol (LDL-C) (100mg/dL) [ Time Frame: baseline, Week 8 ]
    The ratio of patients who reached the treatment target (100mg/dL) of LDL-C at Week 8 compared to the baseline

  2. 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) [ Time Frame: baseline, Week 8 ]
    Variation of HbA1C, Glycated albumin, Homeostasis model assessment Insulin resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) at Week 8 compared to the baseline resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) change form the baseline at Week 8

  3. 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) [ Time Frame: baseline, Week 8 ]
    Variation of 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) at Week 8 compared to the baseline Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) change form the base line at Week 8

  4. Thiobarbituric acid reactive substances(TBARs) [ Time Frame: baseline, Week 8 ]
    Absolute value change of Thiobarbituric acid reactive substances(TBARs) at Week 8 compared to baseline to baseline.

  5. Fibroblast Growth Factor 21 [ Time Frame: baseline, Week 8 ]
    Absolute value change of Fibroblast Growth Factor 21 at Week 8 compared to baseline.



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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217409


Contacts
Contact: Hojin Lee 82 2 828 0548 hjlee@yuhan.co.kr
Contact: Gahee Choi 82 2 70 4504 6700 Gahee.Choi@linical.com

Locations
Korea, Republic of
Soon Chun Hyang University Hospital Cheonan Recruiting
Cheonan, Korea, Republic of
Soon Chun Hyang University Hospital Gumi Recruiting
Gumi, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon Recruiting
Gyeonggi-do, Korea, Republic of
Soon Chun Hyang University Hospital Seoul Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
Linical Korea

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT03217409     History of Changes
Other Study ID Numbers: YMC022
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypercholesterolemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Rosuvastatin Calcium
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors