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

Sponsor
IlDong Pharmaceutical Co Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT02262143
Collaborator
(none)
362
Enrollment
1
Location
2
Arms
31
Duration (Months)
11.7
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
362 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Combination Therapy of Rosuvastatin and Fenofibrate Versus Rosuvastatin Monotherapy in Mixed Dyslipidemia Patients
Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

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.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The mean percent change of Non-HDL Cholesterol [from baseline at week 8]

    Secondary Outcome Measures

    1. The mean change, percent change of Non-LDL-C [from baseline at week 4]

    2. The mean change of Non-LDL-C [from baseline at week 8]

    3. The mean percent change of LDL-C, HDL-C, VLDL-C, TG, TC, Apo-AI, Apo-B [from baseline at week 4, 8]

    4. The achievement rate of Non-HDL-C<130mg/dl [from baseline at week 4, 8]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ildong Pharm. Seoul Korea, Republic of

    Sponsors and Collaborators

    • IlDong Pharmaceutical Co Ltd

    Investigators

    • Principal Investigator: Jeongtaeck Woo, M.D., Ph.D, Kyunghee University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    IlDong Pharmaceutical Co Ltd
    ClinicalTrials.gov Identifier:
    NCT02262143
    Other Study ID Numbers:
    • ID-ROFE-301
    First Posted:
    Oct 10, 2014
    Last Update Posted:
    Aug 24, 2018
    Last Verified:
    Aug 1, 2018
    Additional relevant MeSH terms:
    Dyslipidemias
    Rosuvastatin Calcium
    Fenofibrate

    Study Results

    No Results Posted as of Aug 24, 2018