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

NCT02451098 | Completed Phase 3

• 1 other identifier: 152PDL14025
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Change form baseline in LDL-C

  up to week 8

Secondary Outcomes (12)

• Change form baseline in LDL-C

  up to week 20

• Change form baseline in Total cholesterol

  up to week 20

• Change form baseline in Triglyceride

  up to week 20

• Change form baseline in HDL-C

  up to week 20

• Change form baseline in Non-HDL-C

  up to week 20

Other Outcomes (1)

• Evaluate safety of CKD-391 from adverse events, laboratory test results, physical examination, vital signs.

  up to week 20

Study Arms (6)

Atorvastatin10mg, Ezetimibe10mg

EXPERIMENTAL

Atorvastatin10mg, Ezetimibe10mg will be administered (Duration 8 weeks)

Drug: Atorvastatin10mg, Ezetimibe10mg

Atorvastatin10mg, Ezetimibe placebo

ACTIVE COMPARATOR

Atorvastatin10mg, placebo will be administered (Duration 8 weeks)

Drug: Atorvastatin10mg, Ezetimibe placebo

Atorvastatin20mg, Ezetimibe10mg

EXPERIMENTAL

Atorvastatin20mg, Ezetimibe10mg will be administered (Duration 8 weeks)

Drug: Atorvastatin20mg, Ezetimibe10mg

Atorvastatin20mg, Ezetimibe placebo

ACTIVE COMPARATOR

Atorvastatin20mg, placebo will be administered (Duration 8 weeks)

Drug: Atorvastatin20mg, Ezetimibe placebo

Atorvastatin40mg, Ezetimibe10mg

EXPERIMENTAL

Atorvastatin40mg, Ezetimibe10mg will be administered (Duration 8 weeks)

Drug: Atorvastatin40mg, Ezetimibe10mg

Atorvastatin40mg, Ezetimibe placebo

ACTIVE COMPARATOR

Atorvastatin40mg, placebo will be administered (Duration 8 weeks)

Drug: Atorvastatin40mg, Ezetimibe placebo

Interventions

Atorvastatin10mg, Ezetimibe10mg DRUG

Atorvastatin10mg, Ezetimibe 10mg (Duration: 8weeks)

Also known as: CKD-391

Atorvastatin10mg, Ezetimibe10mg

Atorvastatin10mg, Ezetimibe placebo DRUG

Atorvastatin10mg, Ezetimibe placebo(Duration: 8 weeks)

Also known as: Lipitor

Atorvastatin10mg, Ezetimibe placebo

Atorvastatin20mg, Ezetimibe10mg DRUG

Atorvastatin20mg, Ezetimibe 10mg (Duration: 8weeks)

Also known as: CKD-391

Atorvastatin20mg, Ezetimibe10mg

Atorvastatin20mg, Ezetimibe placebo DRUG

Atorvastatin20mg, Ezetimibe placebo(Duration: 8weeks)

Also known as: Lipitor

Atorvastatin20mg, Ezetimibe placebo

Atorvastatin40mg, Ezetimibe10mg DRUG

Atorvastatin40mg, Ezetimibe 10mg (Duration: 8weeks)

Also known as: CKD-391

Atorvastatin40mg, Ezetimibe10mg

Atorvastatin40mg, Ezetimibe placebo DRUG

Atorvastatin40mg, Ezetimibe placebo(Duration: 8weeks)

Also known as: Lipitor

Atorvastatin40mg, Ezetimibe placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Ho-Jung Yoon, PhD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: May 21, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

KR (1)