KOWA COMPANY,LTD.

🇯🇵Japan

Country: 🇯🇵Japan

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Clinical Trials

A Phase III Confirmatory Study of K-877 (Pemafibrate) in Patients With Hypercholesterolemia and Statin Intolerance

Phase 3

Active, not recruiting

Conditions: Hypercholesterolemia

Interventions: Drug: K-877 0.4 mg/day (once daily)
Drug: K-877 0.2 mg/day (once daily)
Drug: Placebo (once daily)

First Posted Date: 2023-06-28

Last Posted Date: 2024-10-10

Lead Sponsor: Kowa Company, Ltd.

Target Recruit Count: 60

Registration Number: NCT05923281

Locations: 🇯🇵
ToCROM Clinic, Tokyo, Japan
🇯🇵
Central Japan International Medical Center, Gifu, Japan
🇯🇵
Kumamoto University Hospital, Kumamoto, Japan

and more 19 locations

A Phase III Confirmatory Study of K-237

Phase 3

Completed

Conditions: Covid19

Interventions: Drug: Placebo 0.3-0.4mg/kg (once daily)
Drug: K-237 0.3-0.4mg/kg (once daily)

First Posted Date: 2021-09-27

Last Posted Date: 2024-05-20

Lead Sponsor: Kowa Company, Ltd.

Target Recruit Count: 1030

Registration Number: NCT05056883

Locations: 🇯🇵
Minami Nagano Clinic, Nagano, Japan
🇯🇵
National Hospital Organization Kanazawa Medical Center, Ishikawa, Japan
🇯🇵
Sakaide City Hospital, Kagawa, Japan

and more 52 locations

A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C

Phase 3

Conditions: Hyperlipidemia

Interventions: Drug: Placebo capsule
Drug: Fenofibrate 200 mg capsule
Drug: K-877 0.1 mg tablet
Drug: Placebo tablet

First Posted Date: 2021-08-10

Last Posted Date: 2021-12-09

Lead Sponsor: Kowa Company, Ltd.

Target Recruit Count: 350

Registration Number: NCT04998981

Locations: 🇨🇳
Huainan First People's Hospital, Anhui, China
🇨🇳
Beijing Hospital, Beijing, China
🇨🇳
The First Affiliated Hospital of Fujian Medical University, Fujian, China

and more 30 locations

A Phase III Long Term Study of K-877 Extended Release Tablet

Phase 3

Completed

Conditions: Dyslipidemias

Interventions: Drug: K-877 ER 0.2 mg/day evening administration (once daily)
Drug: K-877 ER 0.2 mg/day morning administration (once daily)

First Posted Date: 2021-01-20

Last Posted Date: 2022-08-09

Lead Sponsor: Kowa Company, Ltd.

Target Recruit Count: 121

Registration Number: NCT04716595

Locations: 🇯🇵
Kyosokai AMC NISHI-UMEDA Clinic, Osaka, Japan
🇯🇵
Shiraiwa medical clinic, Osaka, Japan
🇯🇵
Cosmos medical corporation Aozora total clinic, Saitama, Japan

and more 11 locations

A Phase III Confirmatory Study of K-877 Extended Release Tablet

Phase 3

Completed

Conditions: Dyslipidemias

Interventions: Drug: K-877 IR 0.2 mg/day (twice daily)
Drug: K-877 ER 0.2 mg/day (once daily)
Drug: K-877 ER 0.4 mg/day (once daily)

First Posted Date: 2021-01-19

Last Posted Date: 2024-06-20

Lead Sponsor: Kowa Company, Ltd.

Target Recruit Count: 356

Registration Number: NCT04714151

Locations: 🇯🇵
Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic, Kanagawa, Japan
🇯🇵
Fukuwa Clinic, Tokyo, Japan
🇯🇵
Medical Corp. Seikoukai New Medical Research System Clinic, Tokyo, Japan

and more 8 locations

K-924 Phase III Confirmatory Study

Phase 3

Completed

Conditions: Hypercholesterolemia

Interventions: Drug: K-924 HD
Drug: K-924 HD Placebo
Drug: K-924 LD
Drug: K-924 LD Placebo

First Posted Date: 2020-02-28

Last Posted Date: 2023-11-29

Lead Sponsor: Kowa Company, Ltd.

Target Recruit Count: 293

Registration Number: NCT04289649

Locations: 🇯🇵
Medical Corporation Heishinkai OCROM Clinic, Osaka, Japan
🇯🇵
Medical Corporation Heishinkai OPHAC Hospital, Osaka, Japan
🇯🇵
Medical Corporation Heishinkai ToCROM Clinic, Tokyo, Japan

K-924 Phase III Long Term Study

Phase 3

Completed

Conditions: Hypercholesterolemia

Interventions: Drug: K-924 LD
Drug: K-924 HD

First Posted Date: 2020-02-28

Last Posted Date: 2023-11-29

Lead Sponsor: Kowa Company, Ltd.

Target Recruit Count: 110

Registration Number: NCT04289662

Locations: 🇯🇵
Chubu Rosai Hospital, Aichi, Japan
🇯🇵
Daido Clinic, Aichi, Japan
🇯🇵
Nippon Kokan Fukuyama Hospital, Hiroshima, Japan

and more 10 locations

A Clinical Pharmacology Study of K-877 Controlled Release Tablet

Phase 2

Completed

Conditions: Dyslipidemias

Interventions: Drug: K-877 IR 0.2 mg/day
Drug: K-877 CR 0.4 mg/day
Drug: K-877 CR 0.8 mg/day

First Posted Date: 2019-09-06

Last Posted Date: 2021-04-09

Lead Sponsor: Kowa Company, Ltd.

Target Recruit Count: 60

Registration Number: NCT04079530

Locations: 🇯🇵
Medical Corporation Heishinkai OPHAC Hospital, Osaka, Japan

A Study to Evaluate the Safety of K-755 in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Placebo Part A (SAD)
Drug: K-755 Part B (MAD)
Drug: K-755 Part C (FE)
Drug: K-755 Part A (SAD)
Drug: K-755 Part D (FE)
Drug: Placebo Part B (MAD)
Drug: Placebo Part E (MAD)
Drug: K-755 Part E (MAD)

First Posted Date: 2018-01-29

Last Posted Date: 2020-01-28

Lead Sponsor: Kowa Company, Ltd.

Target Recruit Count: 121

Registration Number: NCT03414294

Locations: 🇦🇺
CMAX, Clinical Research Pty Ltd, Adelaide, South Australia, Australia

A Study of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)

Phase 2

Completed

Conditions: Non-Alcoholic Fatty Liver Disease

Interventions: Drug: Placebo
Drug: K-877

First Posted Date: 2017-11-22

Last Posted Date: 2021-04-09

Lead Sponsor: Kowa Company, Ltd.

Target Recruit Count: 118

Registration Number: NCT03350165

Locations: 🇯🇵
Fukuwa Clinic, Chuo-ku, Tokyo, Japan
🇯🇵
Fukuoka University Hospital, Fukuoka, Fukuoka, Japan
🇯🇵
Niigata University Medical & Dental Hospital, Niigata, Niigata, Japan

and more 13 locations

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