Status:
COMPLETED
A Clinical Pharmacology Study of K-877 Controlled Release Tablet
Lead Sponsor:
Kowa Company, Ltd.
Conditions:
Dyslipidemias
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
A study to compare the efficacy, safety, and pharmacokinetics of K-877 controlled release tablets with a current normal K-877 tablet in dyslipidemia.
Eligibility Criteria
Inclusion
- Patients with dyslipidemia had to be age 20 years or older at written informed consent(ICF)
- Men and postmenopausal women.
- Patients who have received dietary or exercise guidance from 12 weeks prior to Screening.
- Patients who have clinical laboratory records with fasting serum TG ≥ 150 mg / dL (or ≥ 200 mg / dL if not fasting) within 6 months before written informed consent.
- Patients with a fasting serum TG ≥ 150 mg / dL at Screening.
Exclusion
- Patients with a fasting serum TG ≥ 500 mg / dL at Screening
- Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
- Patients who have malabsorption or those who have had the history, or who have undergone other surgical procedures that may affect absorption (excluding appendectomy or hernia treatment etc)
- Patients with uncontrolled thyroid disease
- Patients with uncontrolled diabetes as defined by a HbA1c(NGSP) ≥ 8.0％ at Screening
- Persons with uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg)
- Patients with an AST or ALT three times the upper limit at Screening
- Patients with cirrhosis or those with biliary obstruction
- Patients with malignant tumor or those who are judged to have a high risk of recurrence
- Patients who have collected 400 mL or more of whole blood within 16 weeks, or 200 mL or more of whole blood within 4 weeks, or blood samples (plasma and platelet components) within 2 weeks before Screening
- Patients with a history of serious drug allergies (anaphylactic shock, etc.)
- Patients with a history of hypersensitivity to pemafibrate, patients who have stopped taking pemafibrate for reasons of insufficient efficacy or safety
- Patients who participate in other clinical trials at the time of written informed consent or who have received clinical trials other than placebo for less than 16 weeks
- Patients who have been determined inappropriate by the investigator or subinvestigator
Key Trial Info
Start Date :
September 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04079530
Start Date
September 13 2019
End Date
December 24 2019
Last Update
October 6 2025
Active Locations (1)
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1
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Japan, 532-0003