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Clinical Trial to Evaluate the Efficacy and Safety of Pravafenix Cap to Verify the Superiority Than Atorvastatin

NCT02166593 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2018-09-28

No results posted yet for this study

Summary

1. Target disease : Patients with combined dyslipidemia with adequately controlled LDL-C but inadequately controlled triglyceride level by atorvastatin monotherapy
2. Study objective : The objective of this study is to demonstrate that Pravafenix Cap. is clinically superior to atorvastatin by evaluating a percent change in Non-HDL-C in each group after 8 weeks treatment with atorvastatin or Pravafenix Cap. (pravastatin sodium/fenofibrate) in patients with adequately controlled LDL-C but inadequately controlled triglyceride level by atorvastatin monotherapy in a multicenter, randomized, double blind setting.
3. Phase and design : A multicenter, double blind, randomized, active controlled, parallel-design, Phase 3 study
4. Duration of study : 12 months from the IRB approval date
5. Duration of administration : 4-week single blind run-in period plus 8-week double blind treatment period

Conditions

  • Combined Dyslipidemia

Interventions

DRUG

Pravastatin40mg/Fenofibrate160mg

Pravafenix(Pravastatin40mg/Fenofibrate160mg)

DRUG

Atorvastatin Sodium 10mg

Lipitor 10mg(Atorvastatin Sodium)

Sponsors & Collaborators

  • Yooyoung Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hyo-Soo Kim, M.D. · Seoul National University Hospital, Department of Internal Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2018-01-31
Completion
2018-01-31

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 NCT02166593 on ClinicalTrials.gov