JPRN-jRCTs071190049
Completed
未知
Effect of pemafibrate on vascular endothelial function estimated by flow-mediated dilatation in hyperlipidemia patients with type 2 diabetes mellitus; multicenter, randomized controlled, open label, ethyl icosapentate-controlled trial in Kagoshima (PARADISE in Kagoshima study) - PARADISE in Kagoshima study
ishio Yoshihiko0 sites100 target enrollmentMarch 6, 2020
Conditionshyperlipidemia, Type 2 Diabetes Mellitus
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- hyperlipidemia, Type 2 Diabetes Mellitus
- Sponsor
- ishio Yoshihiko
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who meet all of the following criteria are included in this study:
- •1\.Patients with hyperlipidemia whose casual triglyceride is 175 mg/dL or higher, and 1000 mg/dL or lower, or whose fasting triglyceride is 150 mg/dL or higher, and 1000 mg/dL or lower.
- •2\.Patients who are diagnosed as type 2 diabetes mellitus, and whose carbohydrate metabolism is stable (difference in HbA1c of the latest two measures are less than 1%)
- •3\.Male and female aged 20 years or older, and younger than 80 years when giving their consent
- •4\.Patients who give their consent in a written form
Exclusion Criteria
- •Patients who fall into any of the following criteria are excluded from participating in the study:
- •1\.Patients with type 1 diabetes mellitus
- •2\.Patients with unstable glycemic control (HbA1c in the latest 12 weeks is 9% or higher)
- •3\.Patients with renal impairment (serum creatinine is 1\.5 mg/dL or higher)
- •4\.Patients with history of hypersensitivity against the study agent or the control agent, or who meet contraindication for the study agent or the control agent
- •5\.Patients who used fibrate within 4 weeks before giving their consent
- •6\.Patients who used omega\-3 fatty acid or any supplements with same effect within 12 weeks before giving their consent
- •7\.Patients who used corticosteroid such as prednisolone within 12 weeks before giving their consent.
- •Patients who used corticosteroid of 10mg/day or less, and whose disease status is stable, can be included.
- •8\.Patients who changed the usage or dose of hydroxymethylglutaryl\-CoA reductase inhibitor or angiotensin receptor antagonist within 4 weeks before giving their consent
Outcomes
Primary Outcomes
Not specified
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