| Trial ID: | L0401 |
| Source ID: | JPRN-jRCTs031200280
|
| Associated Drug: |
Pemafibrate
|
| Title: |
Randomized clinical trial of pemafibrate on the relative efficacy and safety evaluated in comparison
with fenofibrate in patients with NAFLD and elevated triglyceride - PRESENT study
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NAFLD with hypertriglyceridemia <br>NAFLD
|
| Interventions: |
1. Pemafibrate high dose group<br>Palmodia 0.1 mg tablets are orally administered twice daily, 2 tablets at a time, after breakfast and dinner.<br>2. Pemafibrate low dose group<br>Palmodia 0.1 mg tablets are orally administered twice daily, once after bre
|
| Outcome Measures: |
Change in ALT after 24-week administration1) Change in ALT after 48 weeks of administration<br>2) Changes in liver fibrosis markers after 48 weeks of administration.<br>3) AST, GGT, Cr, BUN, HbA1c, platelets, HOMA-IR, HDL-C, non-HDL-C, LDL-C / HDL-C ratio, TG from baseline to 24 and 48 weeks. Amount of change and rate of change<br>4) (Only for facilities where MRE and USE can be performed) Amount of change in liver fat and liver hardness from baseline in MRE and USE.<br>5) Presence or absence of cardiovascular events, liver disease-related events, and carcinogenesis during the intervention period / observation period<br>6) Changes in body weight, BMI, and abdominal circumference from baseline at 24 and 48 weeks of administration<br>7) Changes in 10-year ASCVD (Atherosclerotic Cardiovascular Disease) risk score<br>8) Percentage of patients with ALT 100 IU / L or higher and / or more than double that at week 0<br>9) Safety (incidence of AEs and ADRs at 48 weeks of treatment)
|
| Sponsor/Collaborators: |
Iwaki Michihiro
|
| Gender: |
All
|
| Age: |
>= 20age old< 80age old
|
| Phases: |
Phase 2
|
| Enrollment: |
360
|
| Study Type: |
Interventional
|
| Study Designs: |
randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose
|
| Start Date: |
28/12/2020
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
17 May 2021
|
| Locations: |
Japan
|
| URL: |
https://jrct.niph.go.jp/latest-detail/jRCTs031200280
|
