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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Mixed Dyslipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental

Rosuvastatin 10 mg, Fenofibrate 160 mg

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Rosuvastatin 10 mg, qd, po

Fenofibrate

Intervention Type DRUG

Fenofibrate 160mg, qd, po

Comparator

Rosuvastatin 10 mg

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

Rosuvastatin 10 mg, qd, po

Interventions

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Rosuvastatin

Rosuvastatin 10 mg, qd, po

Intervention Type DRUG

Fenofibrate

Fenofibrate 160mg, qd, po

Intervention Type DRUG

Other Intervention Names

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Crestor Tab. Lipidil supra Tab.

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No