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Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia

Primary Purpose

Mixed Dyslipidemias

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rosuvastatin
Fenofibrate
Sponsored by
IlDong Pharmaceutical Co Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mixed Dyslipidemias

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 19 ~ 80 years old
  • High risk patient to Coronary Heart Disease

  • At Visit 1(Screening)

    1. Treated with Rosuvastatin 10mg monotherapy 4weeks prior to this study
    2. 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl
  • At Visit 2 (Baseline), 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl

Exclusion Criteria:

  • AST or ALT > 2X ULN
  • Patients with uncontrolled hyperthyroidism (TSH>1.5X ULN)
  • Patients with uncontrolled diabetes (HbA1c ≥ 9%)
  • Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg)
  • Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia within 6 months
  • Patients treated with any investigational drugs within 3 months at the time consents are obtained
  • Not eligible to participate for the study at the discretion of investigator

Sites / Locations

  • Ildong Pharm.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Comparator

Arm Description

Rosuvastatin 10 mg, Fenofibrate 160 mg

Rosuvastatin 10 mg

Outcomes

Primary Outcome Measures

The mean percent change of Non-HDL Cholesterol

Secondary Outcome Measures

The mean change, percent change of Non-LDL-C
The mean change of Non-LDL-C
The mean percent change of LDL-C, HDL-C, VLDL-C, TG, TC, Apo-AI, Apo-B
The achievement rate of Non-HDL-C<130mg/dl

Full Information

First Posted
October 7, 2014
Last Updated
August 23, 2018
Sponsor
IlDong Pharmaceutical Co Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02262143
Brief Title
Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia
Official Title
Efficacy and Safety of Combination Therapy of Rosuvastatin and Fenofibrate Versus Rosuvastatin Monotherapy in Mixed Dyslipidemia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IlDong Pharmaceutical Co Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center, double-blind, phase 3 study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Dyslipidemias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
362 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Rosuvastatin 10 mg, Fenofibrate 160 mg
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Rosuvastatin 10 mg
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor Tab.
Intervention Description
Rosuvastatin 10 mg, qd, po
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Other Intervention Name(s)
Lipidil supra Tab.
Intervention Description
Fenofibrate 160mg, qd, po
Primary Outcome Measure Information:
Title
The mean percent change of Non-HDL Cholesterol
Time Frame
from baseline at week 8
Secondary Outcome Measure Information:
Title
The mean change, percent change of Non-LDL-C
Time Frame
from baseline at week 4
Title
The mean change of Non-LDL-C
Time Frame
from baseline at week 8
Title
The mean percent change of LDL-C, HDL-C, VLDL-C, TG, TC, Apo-AI, Apo-B
Time Frame
from baseline at week 4, 8
Title
The achievement rate of Non-HDL-C<130mg/dl
Time Frame
from baseline at week 4, 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 19 ~ 80 years old High risk patient to Coronary Heart Disease At Visit 1(Screening) Treated with Rosuvastatin 10mg monotherapy 4weeks prior to this study 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl At Visit 2 (Baseline), 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl Exclusion Criteria: AST or ALT > 2X ULN Patients with uncontrolled hyperthyroidism (TSH>1.5X ULN) Patients with uncontrolled diabetes (HbA1c ≥ 9%) Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg) Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia within 6 months Patients treated with any investigational drugs within 3 months at the time consents are obtained Not eligible to participate for the study at the discretion of investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeongtaeck Woo, M.D., Ph.D
Organizational Affiliation
Kyunghee University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ildong Pharm.
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia

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