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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01725646
Recruitment Status : Completed
First Posted : November 14, 2012
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
Excelsior

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

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: Omacor® Drug: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Placebo-controlled Study to Assess the Efficacy and Safety of Omacor® in Taiwanese Hypertriglyceridemic Patients
Study Start Date : July 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Omacor® 4 g
Subjects in this group will take 4 g of Omacor® everyday.
Drug: Omacor®
Subjects in 4 g and 2 g Omacor® will take this drug
Other Name: Omega-3-acid ethyl ester 90

Active Comparator: Omacor® 2 g
Subjects in this group will take 2 g of Omacor® and 2 g of placebo everyday.
Drug: Omacor®
Subjects in 4 g and 2 g Omacor® will take this drug
Other Name: Omega-3-acid ethyl ester 90

Placebo Comparator: Placebo
Subjects in this group will take 4 g of placebo everyday.
Drug: Placebo
Subjects in placebo group will take this drug
Other Name: Olive oil




Primary Outcome Measures :
  1. Change in Triglycerides from baseline [ Time Frame: baseline and 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725646


Locations
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Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
National Cheng Kung University Hospital
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 100
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
Excelsior
Investigators
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Principal Investigator: Chuen-Den Tseng, M.D., PhD. NTUH
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Responsible Party: Excelsior
ClinicalTrials.gov Identifier: NCT01725646    
Other Study ID Numbers: OM3-99001
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: May 19, 2014
Last Verified: May 2014
Keywords provided by Excelsior:
Hypertriglyceridemia, omega-3-acid ethyl ester
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases