An Efficacy and Safety Study of Omacor® in Taiwanese Hype... | NCT01725646

Studies
An Efficacy and Safety Study of Omacor® in Taiwanese Hypertriglyceridemic Patients

NCT01725646

Sponsor

Excelsior

Status

Completed

Last Update Posted

May 19, 2014Estimated

Enrollment

253Actual

Phase

Phase 3

Conditions

Hypertriglyceridemia

Interventions

Omacor®
Placebo

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jul 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Oct 29, 2012

First Submission Date that Met QC Criteria

Nov 13, 2012

First Posted Date

Nov 14, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2014

Last Update Posted Date

May 19, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients
Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients

Detailed Description

The primary end point is to evaluate the efficacy and safety of Omacor in Taiwanese hypertriglyceridemia patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

253Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Omacor®	Drug	Subjects in 4 g and 2 g Omacor® will take this drug	Omacor® 2 g Omacor® 4 g

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Triglycerides from baseline		baseline and 8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chuen-Den Tseng, M.D., PhD.	NTUH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taichung Veterans General Hospital		Taichung	Taiwan	40705	Taiwan
National Cheng Kung University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D015228	Hypertriglyceridemia

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C405603	Omacor
D000069463	Olive Oil

Ancestor Terms

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids

Browse Leaves

Not provided

Browse Branches

Not provided