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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Excelsior
ClinicalTrials.gov Identifier:
NCT01725646
First received: October 29, 2012
Last updated: May 16, 2014
Last verified: May 2014
  Purpose
  1. Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients
  2. Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients

Condition Intervention Phase
Hypertriglyceridemia
Drug: Omacor®
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Excelsior:

Primary Outcome Measures:
  • Change in Triglycerides from baseline [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 253
Study Start Date: July 2011
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725646

Locations
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
Principal Investigator: Chuen-Den Tseng, M.D., PhD. NTUH
  More Information

No publications provided

Responsible Party: Excelsior
ClinicalTrials.gov Identifier: NCT01725646     History of Changes
Other Study ID Numbers: OM3-99001
Study First Received: October 29, 2012
Last Updated: May 16, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by Excelsior:
Hypertriglyceridemia, omega-3-acid ethyl ester

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 14, 2014