A Phase III Confirmatory Study of K-877 (Pemafibrate) in Patients With Hypercholesterolemia and Statin Intolerance
- 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
- π―π΅
Central Japan International Medical Center, Gifu, Japan
π―π΅Kumamoto University Hospital, Kumamoto, Japan
π―π΅Fukuwa Clinic, Tokyo, Japan
A Phase III Confirmatory Study of K-237
- 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
- π―π΅
Hosokawa Surgical Clinic, Aichi, Japan
π―π΅Nagoya City University West Medical Center, Aichi, Japan
π―π΅Nagoya City University East Medical Center, Aichi, Japan
A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C
- Conditions
- Hyperlipidemia
- Interventions
- First Posted Date
- 2021-08-10
- Last Posted Date
- 2025-05-23
- Lead Sponsor
- Kowa Company, Ltd.
- Target Recruit Count
- 353
- Registration Number
- NCT04998981
- Locations
- π¨π³
Huainan First People's Hospital, Anhui, China
π¨π³Beijing Anzhen Hospital, Capital Medical University, Beijing, China
π¨π³Beijing Hospital, Beijing, China
A Phase III Long Term Study of K-877 Extended Release Tablet
- 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
- π―π΅
Saiseikai Futsukaichi Hospital, Fukuoka, Japan
π―π΅National Hospital Organization Takasaki General Medical Center, Gunma, Japan
π―π΅Hasegawa Medicine Clinic, Hokkaido, Japan
A Phase III Confirmatory Study of K-877 Extended Release Tablet
- 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
- π―π΅
Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic, Kanagawa, Japan
π―π΅Medical Corporation Heishinkai OCROM Clinic, Osaka, Japan
π―π΅Dojinkinenkai Meiwa Hospital, Tokyo, Japan
K-924 Phase III Confirmatory Study
- Conditions
- Hypercholesterolemia
- Interventions
- Drug: K-924 HDDrug: K-924 HD PlaceboDrug: K-924 LDDrug: 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
- π―π΅
Medical Corporation Heishinkai OCROM Clinic, Osaka, Japan
π―π΅Medical Corporation Heishinkai OPHAC Hospital, Osaka, Japan
π―π΅Medical Corporation Heishinkai ToCROM Clinic, Tokyo, Japan
K-924 Phase III Long Term Study
- Conditions
- Hypercholesterolemia
- Interventions
- Drug: K-924 LDDrug: 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
- π―π΅
Chubu Rosai Hospital, Aichi, Japan
π―π΅Daido Clinic, Aichi, Japan
π―π΅Nakamura Cardiovascular Clinic, Fukuoka, Japan
A Clinical Pharmacology Study of K-877 Controlled Release Tablet
- Conditions
- Dyslipidemias
- Interventions
- Drug: K-877 IR 0.2 mg/dayDrug: K-877 CR 0.4 mg/dayDrug: 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
- π―π΅
Medical Corporation Heishinkai OPHAC Hospital, Osaka, Japan
A Study to Evaluate the Safety of K-755 in Healthy Volunteers
- 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
- π¦πΊ
CMAX, Clinical Research Pty Ltd, Adelaide, South Australia, Australia
A Study of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
- 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
- π―π΅
Aomori Prefectural Central Hospital, Aomori, Aomori, Japan
π―π΅Asahikawa Medical University, Asahikawa, Hokkaido, Japan
π―π΅Fukuwa Clinic, Chuo-ku, Tokyo, Japan