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

Efficacy and Safety of Combination Therapy of Rosuvastatin and Fenofibrate Versus Rosuvastatin Monotherapy in Mixed Dyslipidemia Patients

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

Study Overview

• Status: Completed
• Conditions: Mixed Dyslipidemias
• Intervention / Treatment: Drug: Rosuvastatin; Drug: Fenofibrate

• Study Type: Interventional
• Enrollment (Actual): 362
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Ildong Pharm.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Rosuvastatin 10 mg, Fenofibrate 160 mg	Drug: Rosuvastatin; Rosuvastatin 10 mg, qd, po; Other Names: Crestor Tab.; Drug: Fenofibrate; Fenofibrate 160mg, qd, po; Other Names: Lipidil supra Tab.
Active Comparator: Comparator; Rosuvastatin 10 mg	Drug: Rosuvastatin; Rosuvastatin 10 mg, qd, po; Other Names: Crestor Tab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The mean percent change of Non-HDL Cholesterol	from baseline at week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
The mean change, percent change of Non-LDL-C	from baseline at week 4
The mean change of Non-LDL-C	from baseline at week 8
The mean percent change of LDL-C, HDL-C, VLDL-C, TG, TC, Apo-AI, Apo-B	from baseline at week 4, 8
The achievement rate of Non-HDL-C<130mg/dl	from baseline at week 4, 8

Collaborators and Investigators

• Sponsor: IlDong Pharmaceutical Co Ltd
• Investigators: Principal Investigator: Jeongtaeck Woo, M.D., Ph.D, Kyunghee University Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: October 7, 2014
• First Submitted That Met QC Criteria: October 7, 2014
• First Posted (Estimate): October 10, 2014

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Fenofibrate
• Other Study ID Numbers: ID-ROFE-301