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Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin

NCT01956201 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 476

Last updated 2015-02-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of Atorvastatin and Fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients.

Conditions

  • Mixed Hyperlipidemia

Interventions

DRUG

Atorvastatin 20mg

\[Atorvastatin Run-in Period\] Take Atorvastatin 20mg 1 tablet once a day (after breakfast) \[Treatment Period\] Take Atrovastatin 20mg/Fenofibrate 160mg or Atorvastiatin 20mg/Placebo of Finofibrate 160mg 2 tablet once a day (after breakfast) \[Extension Period\] Take Atrovastatin 20mg, Fenofibrate 160mg 2 tablet once a day (after breakfast)

DRUG

Fenofibrate 160mg

Refer to Intervention Description of Atorvastatin 20mg

OTHER

Placebo (Fenofibrate 160 mg)

Refer to Intervention Description of Atorvastatin 20mg

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • MoonKyu Lee, M.D., Ph.D. · Samsung Medical Center - Seoul

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01956201 on ClinicalTrials.gov