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

Phase 3

Completed

• Conditions: Mixed Dyslipidemias
• Interventions: Drug: Rosuvastatin; Drug: Fenofibrate

• Registration Number: NCT02262143
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-07
• Study First Submitted QC: 2014-10-07
• Study First Posted: 2014-10-10
• Study Start: 2014-11
• Primary Completion: 2016-10
• Study Completion: 2017-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Rosuvastatin	Rosuvastatin 10 mg, Fenofibrate 160 mg
Comparator	Rosuvastatin	Rosuvastatin 10 mg
Experimental	Fenofibrate	Rosuvastatin 10 mg, Fenofibrate 160 mg

Primary Outcome Measures

Name	Time	Method
The mean percent change of Non-HDL Cholesterol	from baseline at week 8

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ildong Pharm.; 🇰🇷 Seoul, Korea, Republic of