- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02305355
Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia
December 1, 2014 updated by: Kuhnil Pharmaceutical Co., Ltd.
Assess efficacy and safety of Omacor® 4g with statin treatment for lowering TG levels in subjects with type 2 Diabetes combined with hyperlipidemia
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bucheon, Korea, Republic of
- Bucheon St. Mary's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- LDL-C < 100mg/dL, TG > 150mg/dL, patients on statin treatment for at least 6 weeks prior to randomization.
- Type 2 Diabetes
- HbA1c ≤ 10.0
Exclusion Criteria:
- Type 1 Diabetes
- Patients with PPAR gamma agonist therapy
- Patients with acute MI, Unstable angina within 6 months
- History of malignant tumor within 2 years
- Women with pregnant, breast-feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Omega-3-acids ethylesters 90 4g, any statin
|
Other Names:
|
Active Comparator: any statin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The mean percent change of Triglyceride(TG)
Time Frame: from baseline at week 16
|
from baseline at week 16
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The mean percent change of Total Cholesterol(TC)
Time Frame: from baseline at week 16
|
from baseline at week 16
|
The mean percent change of LDL-C
Time Frame: from baseline at week 16
|
from baseline at week 16
|
The mean percent change of HDL-C
Time Frame: from baseline at week 16
|
from baseline at week 16
|
The mean percent change of HBA1c
Time Frame: from baseline at week 16
|
from baseline at week 16
|
The mean percent change of FPG
Time Frame: from baseline at week 16
|
from baseline at week 16
|
The mean percent change of hs-CRP
Time Frame: from baseline at week 16
|
from baseline at week 16
|
The mean percent change of PAI-1
Time Frame: from baseline at week 16
|
from baseline at week 16
|
The mean percent change of Apolipoprotein A1
Time Frame: from baseline at week 16
|
from baseline at week 16
|
The mean percent change of apolipoprotein B
Time Frame: from baseline at week 16
|
from baseline at week 16
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
November 25, 2014
First Submitted That Met QC Criteria
December 1, 2014
First Posted (Estimate)
December 2, 2014
Study Record Updates
Last Update Posted (Estimate)
December 2, 2014
Last Update Submitted That Met QC Criteria
December 1, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypertriglyceridemia
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
- Rosuvastatin Calcium
- Pravastatin
- Simvastatin
Other Study ID Numbers
- 08-OM-9412
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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