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

NCT02262143 | Completed Phase 3

• 1 other identifier: ID-ROFE-301
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

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

Conditions

Mixed Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• The mean percent change of Non-HDL Cholesterol

  from baseline at week 8

Secondary Outcomes (4)

• 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

Study Arms (2)

Experimental

EXPERIMENTAL

Rosuvastatin 10 mg, Fenofibrate 160 mg

Drug: Rosuvastatin; Drug: Fenofibrate

Comparator

ACTIVE COMPARATOR

Rosuvastatin 10 mg

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

Rosuvastatin 10 mg, qd, po

Also known as: Crestor Tab.

Comparator; Experimental

Fenofibrate DRUG

Fenofibrate 160mg, qd, po

Also known as: Lipidil supra Tab.

Experimental

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~ 80 years old
• High risk patient to Coronary Heart Disease
• At Visit 1(Screening)
• Treated with Rosuvastatin 10mg monotherapy 4weeks prior to this study
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

Study Sites (1)

Ildong Pharm.

Seoul, South Korea

Location

MeSH Terms

Interventions

Rosuvastatin Calcium; Fenofibrate

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Phenols; Ketones

Study Officials

• Jeongtaeck Woo, M.D., Ph.D

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 10, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: June 1, 2017
• Last Updated: August 24, 2018

Record last verified: 2018-08

Locations

KR (1)