NCT02035215

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of combination therapy of omega-3-acids ethylesters 90/Atorvastatin calcium in type Ⅱb hyperlipidemia

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 20, 2014

Status Verified

March 1, 2014

Enrollment Period

9 months

First QC Date

January 10, 2014

Last Update Submit

March 19, 2014

Conditions

Hyperlipidemia, Familial Combined

Keywords

Hyperlipidemia, Familial CombinedOmega 3 acids ethylesters 90Atorvastatin

Outcome Measures

Primary Outcomes (1)

  • The mean percent change of Triglyceride(TG)

    from baseline at week 8

Secondary Outcomes (2)

  • The mean percent change of Triglyceride(TG)

    from baseline at week 4

  • The mean percent change of Total Cholesterol(TC), LDL-C, HDL-C

    from baseline at week 4,8

Study Arms (2)

Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g

EXPERIMENTAL

Atorvastatin calcium 20mg, Omega-3-acids ethylesters 90 4g: po, q.d

Drug: Atorvastatin 20mgDrug: Omega-3-acids ethylesters 90 4g

Atorvastatin 20mg, Placebo

PLACEBO COMPARATOR

Atorvastatin calcium 20mg, Placebo for Omega-3-acids ethylesters 90 4g: po, q.d

Drug: Atorvastatin 20mgOther: Placebo(Omega-3-acids ethylesters 90)

Interventions

Atorvastatin 20mgDRUG
Also known as: Lipitor 20mg
Atorvastatin 20mg, Omega-3-acids ethylesters 90 4gAtorvastatin 20mg, Placebo
Omega-3-acids ethylesters 90 4gDRUG
Also known as: Omacor Soft Capsule 4g
Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g
Placebo(Omega-3-acids ethylesters 90)OTHER
Atorvastatin 20mg, Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LDL≥160mg/dl, 200mg/dl≤TG\<500mg/dl
  • In the case of smokers, he agrees should be smoke-free
  • In the case of women of childbearing age, urine pregnancy test must be negative

You may not qualify if:

  • Patients with acute artery disease within 3 months
  • History of revascularization procedure or aneurism operation within 6months
  • Patients with myopathy, rhabdomyolysis
  • Patients with pancreatitis
  • Patients with HIV positive
  • History of malignant tumor within 2 years
  • Patients must be treated with medications prohibited for concomitant use during study period
  • Patients with uncontrolled hypertension(SBP\>180mmHg or DBP\>110mmHg)
  • Serum Creatinine\>1.2mg/dl(female), \>1.4mg/dl(male)
  • AST or ALT \> 2X ULN
  • CPK \> 2X ULN
  • Patients with galactose intolerance or Lapp lactase deficiency, glucose-galactose malabsorption
  • Allergy or Hypersensitive to investigational drug
  • History of drug or alcohol abuse within 2 years
  • In the case of smokers, who do not intend to non smoking
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hallym University Sacred Heart Hospital

Anyang, Gyeonggi, 431-070, South Korea

ACTIVE NOT RECRUITING

Gachon University Gil Hospital

Incheon, 405-760, South Korea

NOT YET RECRUITING

Korea University Guro Hospital

Seoul, 152-703, South Korea

RECRUITING

Uijongbu St. Mary's Hospital

Uijongbu, Gyeonggi, 480-717, South Korea

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Hyperlipidemia, Familial Combined

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Hong Seog Seo, Ph.D.

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

  • Hee Kyoung Cheon, Ph.D.

    Uijongbu St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

  • Sang-Ho Jo, Ph.d.

    Hallym University Medical Center

    PRINCIPAL INVESTIGATOR

  • Mi-Seung Shin, Ph.D

    Gachon University Gil Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuhnil Clinical Research Team

CONTACT

+82-2-2175-9760jmhong@kuhnil.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 14, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

March 20, 2014

Record last verified: 2014-03

Locations

KR(4)