A Post-Marketing Clinical Trial of Pemafibrate in Patients with Hypercholesterolemia and Inadequate Response to Statins
NCT07634484 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-07-13
Summary
To investigate the efficacy and safety of Pemafibrate 0.2 mg/day or 0.4 mg/day for 12 weeks in patients with hypercholesterolemia and inadequate response to statins, using placebo as a control.
Conditions
Interventions
- DRUG
-
Pemafibrate 0.2 mg/day
Administered orally once daily
- DRUG
-
Pemafibrate 0.4 mg/day
Administered orally once daily
- DRUG
-
Administered orally once daily
Sponsors & Collaborators
-
Kowa Company, Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-01
- Primary Completion
- 2027-07-31
- Completion
- 2027-07-31
Countries
- Japan
Study Locations
More Related Trials
-
A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia
NCT04784442 ·Status: COMPLETED ·Phase: PHASE2
-
Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia
NCT01243151 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluate the Pharmacokinetics and Safety of HCP1306 and Co-administration of HGP0816, HGP1404 in Healthy Male Volunteers
NCT02941848 ·Status: COMPLETED ·Phase: PHASE1
-
A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.
NCT05421078 ·Status: COMPLETED ·Phase: PHASE2
-
A 12-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05244)
NCT00704444 ·Status: COMPLETED
-
A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects
NCT01720537 ·Status: COMPLETED ·Phase: PHASE1
-
Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)
NCT00211705 ·Status: COMPLETED ·Phase: PHASE4
-
A Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin/Fenofibrate in Complex-dyslipidemia
NCT03618797 ·Status: COMPLETED ·Phase: PHASE3
-
Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors
NCT00344175 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C
NCT04998981 ·Status: COMPLETED ·Phase: PHASE3
-
Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin
NCT01592240 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Efficacy and Safety of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-832)
NCT02741245 ·Status: COMPLETED ·Phase: PHASE3
-
Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects
NCT02055976 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Study of BMS-823778 in Subjects With Hypercholesterolemia
NCT01112423 ·Status: COMPLETED ·Phase: PHASE2
-
Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
NCT00344370 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia
NCT02260635 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of LY2484595 in Japanese Subjects
NCT01375075 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of K-312 in Healthy Subjects
NCT02676596 ·Status: COMPLETED ·Phase: PHASE1
-
Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides
NCT07442630 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia
NCT01166633 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of Fenofibrate and Niacin in Patients With Hypertriglyceridemia and Low High-Density Lipoprotein (HDL)-Cholesterol
NCT01122355 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of LY4065967 in Healthy Japanese Participants
NCT06594159 ·Status: COMPLETED ·Phase: PHASE1
-
The Effects of Pravastatin and Rosuvastatin on Coronary Plaques in Patients With Stable Angina Pectoris
NCT01325818 ·Status: UNKNOWN ·Phase: PHASE4
-
Efficacy and Safety Study of JTT-705 in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia
NCT00688896 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia
NCT02670434 ·Status: WITHDRAWN ·Phase: PHASE3