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Trial record 1 of 1 for:    142-011
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Evaluation of the Safety and Efficacy of Long-term Use of Lotriga

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02153073
First received: May 29, 2014
Last updated: October 20, 2016
Last verified: October 2016
  Purpose
The purpose of this study is to evaluate the safety and efficacy of long-term use of granular capsule formulation of omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in patients with hyperlipidemia in daily medical practice

Condition Intervention
Hyperlipidemia Drug: Omega-3 fatty acid ethyl esters

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lotriga Granular Capsules Special Drug Use Surveillance (Long-term Use Survey)

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Frequency of adverse events [ Time Frame: For 12 months ]
    The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.


Secondary Outcome Measures:
  • Changes from baseline in lipid parameters [ Time Frame: From Baseline and Month12 ]
    For lipid parameters such as triglycerides (TG), total cholesterol (TC), LDL cholesterol (LDL-C), HDL cholesterol (HDL-C), Non-HDL- C, observed values (or converted values) and percent changes (%) from baseline in these valuesare tabulated at each observational point.


Enrollment: 3070
Study Start Date: May 2013
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Omega-3 fatty acid ethyl esters 2 g
Omega-3 fatty acid ethyl esters 2 g, administered orally once or twice daily after meals
Drug: Omega-3 fatty acid ethyl esters
Omega-3 fatty acid ethyl esters granular capsules
Other Name: Lotriga Granular Capsules

Detailed Description:
This special drug use surveillance on long-term use of granular capsule formulation of omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) was designed to investigate the frequency of adverse events in patients with hyperlipidemia The usual adult dosage is 2 g of omega-3 fatty acid ethyl esters administered orally once daily after meals. However, the dosage can be increased up to twice daily (at a dose of 2 g) depending on the patient's triglyceride level.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hyperlipidemia
Criteria

Inclusion Criteria:

  • Patients with hyperlipidemia

Exclusion Criteria:

  • (1) Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage) (2) Patients with a history of hypersensitivity to ingredients in Lotriga Granular Capsules
  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: NCT02153073

Locations
Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02153073     History of Changes
Other Study ID Numbers: 142-011
JapicCTI-142457 ( Registry Identifier: JapicCTI )
Study First Received: May 29, 2014
Last Updated: October 20, 2016

Keywords provided by Takeda:
Pharmacological therapy

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

ClinicalTrials.gov processed this record on June 27, 2017