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KOWA COMPANY,LTD.

πŸ‡―πŸ‡΅Japan
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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
πŸ‡―πŸ‡΅

ToCROM Clinic, Tokyo, Japan

πŸ‡―πŸ‡΅

Central Japan International Medical Center, Gifu, Japan

πŸ‡―πŸ‡΅

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
πŸ‡―πŸ‡΅

Minami Nagano Clinic, Nagano, Japan

πŸ‡―πŸ‡΅

National Hospital Organization Kanazawa Medical Center, Ishikawa, Japan

πŸ‡―πŸ‡΅

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: 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
πŸ‡¨πŸ‡³

Huainan First People's Hospital, Anhui, China

πŸ‡¨πŸ‡³

Beijing Hospital, Beijing, China

πŸ‡¨πŸ‡³

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
πŸ‡―πŸ‡΅

Kyosokai AMC NISHI-UMEDA Clinic, Osaka, Japan

πŸ‡―πŸ‡΅

Shiraiwa medical clinic, Osaka, Japan

πŸ‡―πŸ‡΅

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
πŸ‡―πŸ‡΅

Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic, Kanagawa, Japan

πŸ‡―πŸ‡΅

Fukuwa Clinic, Tokyo, Japan

πŸ‡―πŸ‡΅

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
πŸ‡―πŸ‡΅

Medical Corporation Heishinkai OCROM Clinic, Osaka, Japan

πŸ‡―πŸ‡΅

Medical Corporation Heishinkai OPHAC Hospital, Osaka, Japan

πŸ‡―πŸ‡΅

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
πŸ‡―πŸ‡΅

Chubu Rosai Hospital, Aichi, Japan

πŸ‡―πŸ‡΅

Daido Clinic, Aichi, Japan

πŸ‡―πŸ‡΅

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
πŸ‡―πŸ‡΅

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
πŸ‡¦πŸ‡Ί

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
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
πŸ‡―πŸ‡΅

Fukuwa Clinic, Chuo-ku, Tokyo, Japan

πŸ‡―πŸ‡΅

Fukuoka University Hospital, Fukuoka, Fukuoka, Japan

πŸ‡―πŸ‡΅

Niigata University Medical & Dental Hospital, Niigata, Niigata, Japan

and more 13 locations
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