Status:
COMPLETED
Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia
Lead Sponsor:
IlDong Pharmaceutical Co Ltd
Conditions:
Mixed Dyslipidemias
Eligibility:
All Genders
19-80 years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT02262143
Start Date
November 1 2014
End Date
June 1 2017
Last Update
August 24 2018
Active Locations (1)
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1
Ildong Pharm.
Seoul, South Korea