NCT01725646

Brief Summary

  1. 1.Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients
  2. 2.Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
253

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

4 active sites

Status
completed

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

July 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 19, 2014

Status Verified

May 1, 2014

Enrollment Period

2 years

First QC Date

October 29, 2012

Last Update Submit

May 16, 2014

Conditions

Hypertriglyceridemia

Keywords

Hypertriglyceridemia, omega-3-acid ethyl ester

Outcome Measures

Primary Outcomes (1)

  • Change in Triglycerides from baseline

    baseline and 8 weeks

Study Arms (3)

Omacor® 4 g

ACTIVE COMPARATOR

Subjects in this group will take 4 g of Omacor® everyday.

Drug: Omacor®

Omacor® 2 g

ACTIVE COMPARATOR

Subjects in this group will take 2 g of Omacor® and 2 g of placebo everyday.

Drug: Omacor®

Placebo

PLACEBO COMPARATOR

Subjects in this group will take 4 g of placebo everyday.

Drug: Placebo

Interventions

Omacor®DRUG

Subjects in 4 g and 2 g Omacor® will take this drug

Also known as: Omega-3-acid ethyl ester 90
Omacor® 2 gOmacor® 4 g
PlaceboDRUG

Subjects in placebo group will take this drug

Also known as: Olive oil
Placebo

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has fasting serum TG ≥ 200 mg/dL but no more than 1000 mg/dL

You may not qualify if:

  • Patients had a history of pancreatitis or considered to be at risk of developing pancreatitis
  • Patient had history of a severe cardiovascular event or a revascularization procedure within 6 months prior to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan, 11217, Taiwan

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

OmacorOlive Oil

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Chuen-Den Tseng, M.D., PhD.

    NTUH

    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

October 29, 2012

First Posted

November 14, 2012

Study Start

July 1, 2011

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

May 19, 2014

Record last verified: 2014-05

Locations

TW(4)