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OpenTrials
Completed

NCT Number: NCT02262143

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: A randomized, multi-center, double-blind, phase 3 study

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Key information

Conditions

Mixed Dyslipidemias

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ildong Pharm.

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

Rosuvastatin 10 mg, qd, po

Other names: Crestor Tab.

fenofibrate

Drug

Fenofibrate 160mg, qd, po

Other names: Lipidil supra Tab.

Primary outcomes

  1. The mean percent change of Non-HDL Cholesterol

    Time frame: from baseline at week 8

Secondary outcomes

  1. The mean change, percent change of Non-LDL-C

    Time frame: from baseline at week 4

  2. The mean change of Non-LDL-C

    Time frame: from baseline at week 8

  3. 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

  4. The achievement rate of Non-HDL-C<130mg/dl

    Time frame: from baseline at week 4, 8

Sponsors and collaborators

Lead sponsor

IlDong Pharmaceutical Co Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Oct 10, 2014
Registry last updated
Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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