PROUD48

JRCT ID: jRCTs071200011

Registered date:28/04/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Dyslipidemic patients
• Date of first enrollment: 16/05/2020
• Target sample size: 128
• Study type: Interventional

Intervention(s)

Pemafibrate group:
Take pemafibrate 0.2 mg twice a day in the morning and evening for 16 weeks.
Omega-3 fatty acids group:
Take omega-3 fatty acids 2 g twice a day immediately after meals for 16 weeks.

Outcome(s)

• Primary Outcome: Rate of change of fasting apo B48 levels from baseline at 16 weeks of administration

Secondary Outcome

1)Change from baseline in fasting apo B48 at 16 weeks of administration
2)Rate of change or amount of change at 8 and 16 weeks after administration
3)Relationship between fasting apo B48 and various indices at 16 weeks of administration
4)Incidence of adverse events and diseases

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

1)Patients who are 20 years old or older and 79 years old
or under
2)Patients who have been taking statin for more than 4 weeks
3)Patients with fasting TG levels of 177 mg/dL (2 mmol/L) or higher
4)Patients who showed written consent form

Exclude criteria

1)Patients with fasting TG levels of 500 mg/dL (5.7 mmol/L) or higher
2)Diabetic patients who showed HbA1c levels of 9 % or higher and who need glycemic control with insulin treatment
3)Patients with type 1 diabetes
4)Patients who showed moderate renal dysfunction (serum creatinine levels 1.5 mg/dL or higher)
5)Patients who used fibrates and nicotinic acids within 4 weeks
6)Patients who used omega-3 fatty acids and ethyl icosapentate and the supplements that contained same ingredients within 24 weeks
7)Patients with symptomatic cardiovascular and cerebrovascular disorders
8)Patients with severe infections
9)Patients with acute hepatitis or liver cirrhosis
10)Patients with cancer
11)Patients before or after surgery
12)Women with pregnancy or during breastfeeding
13)Patients who need lipid management with PCSK9 inhibitors or MTP inhibitors
14)Others. Patients who have contraindications to pemafibrate and omega-3 fatty acids

Related Information

• Primary Sponsor: Takeda Yasutaka
• Source(s) of Monetary Support: Kowa Company, Ltd.