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Clinical Trial to Evaluate the Efficacy and Safety of CKD-391

NCT ID: NCT02451098

Last Updated: 2016-01-28

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

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-01-31

Brief Summary

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A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design, Phase III Clinical Trial.

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Detailed Description

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The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-391 once daily for 8 weeks in patients with primary hypercholesterolemia. Furthermore, the extension study for additional 12 weeks is designed to confirm long term safety of CKD-391.

Conditions

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Hyperlipidemia

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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Atorvastatin10mg, Ezetimibe10mg

Atorvastatin10mg, Ezetimibe10mg will be administered (Duration 8 weeks)

Group Type EXPERIMENTAL

Atorvastatin10mg, Ezetimibe10mg

Intervention Type DRUG

Atorvastatin10mg, Ezetimibe 10mg (Duration: 8weeks)

Atorvastatin10mg, Ezetimibe placebo

Atorvastatin10mg, placebo will be administered (Duration 8 weeks)

Group Type ACTIVE_COMPARATOR

Atorvastatin10mg, Ezetimibe placebo

Intervention Type DRUG

Atorvastatin10mg, Ezetimibe placebo(Duration: 8 weeks)

Atorvastatin20mg, Ezetimibe10mg

Atorvastatin20mg, Ezetimibe10mg will be administered (Duration 8 weeks)

Group Type EXPERIMENTAL

Atorvastatin20mg, Ezetimibe10mg

Intervention Type DRUG

Atorvastatin20mg, Ezetimibe 10mg (Duration: 8weeks)

Atorvastatin20mg, Ezetimibe placebo

Atorvastatin20mg, placebo will be administered (Duration 8 weeks)

Group Type ACTIVE_COMPARATOR

Atorvastatin20mg, Ezetimibe placebo

Intervention Type DRUG

Atorvastatin20mg, Ezetimibe placebo(Duration: 8weeks)

Atorvastatin40mg, Ezetimibe10mg

Atorvastatin40mg, Ezetimibe10mg will be administered (Duration 8 weeks)

Group Type EXPERIMENTAL

Atorvastatin40mg, Ezetimibe10mg

Intervention Type DRUG

Atorvastatin40mg, Ezetimibe 10mg (Duration: 8weeks)

Atorvastatin40mg, Ezetimibe placebo

Atorvastatin40mg, placebo will be administered (Duration 8 weeks)

Group Type ACTIVE_COMPARATOR

Atorvastatin40mg, Ezetimibe placebo

Intervention Type DRUG

Atorvastatin40mg, Ezetimibe placebo(Duration: 8weeks)

Interventions

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Atorvastatin10mg, Ezetimibe10mg

Atorvastatin10mg, Ezetimibe 10mg (Duration: 8weeks)

Intervention Type DRUG

Atorvastatin10mg, Ezetimibe placebo

Atorvastatin10mg, Ezetimibe placebo(Duration: 8 weeks)

Intervention Type DRUG

Atorvastatin20mg, Ezetimibe10mg

Atorvastatin20mg, Ezetimibe 10mg (Duration: 8weeks)

Intervention Type DRUG

Atorvastatin20mg, Ezetimibe placebo

Atorvastatin20mg, Ezetimibe placebo(Duration: 8weeks)

Intervention Type DRUG

Atorvastatin40mg, Ezetimibe10mg

Atorvastatin40mg, Ezetimibe 10mg (Duration: 8weeks)

Intervention Type DRUG

Atorvastatin40mg, Ezetimibe placebo

Atorvastatin40mg, Ezetimibe placebo(Duration: 8weeks)

Intervention Type DRUG

Other Intervention Names

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CKD-391 Lipitor CKD-391 Lipitor CKD-391 Lipitor

Eligibility Criteria

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Inclusion Criteria

* Adult, at least 19 years of age.
* Hyperlipidemia patient of LDL-C≤250 mg/dl and TG ≤400 mg/dl
* Patients requiring anti-dyslipidemia drug therapy \[based on the NCEP ATP III(2002)\]
* Drug compliance during Run-in period ≥70%
* Patients must willing to the study and signed an informed consent

Exclusion Criteria

* Patients with myopathy included rhabdomyolysis or CPK level≥2xULN
* Patients with acute arterial disease
* Patients with renal dysfunction or Serum creatinine level ≥2x ULN
* Patients with liver dysfunction or ALT, AST level \> 2xULN
* Patients with medical history within 6 months prior to screening visit (Heart failure, uncontrolled arrhythmia, drug and alcohol abuse history, gastrointestinal disease or surgery, anticoagulation disease)
* Patient with uncontrolled disease (diabetes mellitus as HbA1c level of \> 9.0%, hypertension as SBP≥180mmHg or DBP≥110mmHg, hypothyroidism as TSH≥1.5xULN)
* Patients who have a history or presence of active malignancy within 5 years
* Patients with difficulty of stop taking lipid-lowering agents during run-in period.
* Patients who have taken another investigational drug within 4 weeks prior to screening visit.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ho-Jung Yoon, PhD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

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The catholic university of korea seoul st. Mary's hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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152PDL14025

Identifier Type: -

Identifier Source: org_study_id

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