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

Mixed Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262143
• Other study ID #: ID-ROFE-301
• Status: Completed
• Phase: Phase 3
• Start date: November 2014
• Est. completion date: June 2017

Study information

• Verified date: August 2018
• Source: IlDong Pharmaceutical Co Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: June 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Mixed Dyslipidemias

Intervention

Drug:
• Rosuvastatin
Rosuvastatin 10 mg, qd, po
• Fenofibrate
Fenofibrate 160mg, qd, po

Locations

Country	Name	City	State
Korea, Republic of	Ildong Pharm.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean percent change of Non-HDL Cholesterol		from baseline at week 8
Secondary	The mean change, percent change of Non-LDL-C		from baseline at week 4
Secondary	The mean change of Non-LDL-C		from baseline at week 8
Secondary	The mean percent change of LDL-C, HDL-C, VLDL-C, TG, TC, Apo-AI, Apo-B		from baseline at week 4, 8
Secondary	The achievement rate of Non-HDL-C<130mg/dl		from baseline at week 4, 8