55 completed, 5 unknown, 1 terminated. 29 Phase 1, 14 Phase 3, 9 Phase 4, 6 Phase 2, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 29 | Completed 29 |
| Phase 3 | 14 | Completed 14 |
| Phase 4 | 9 | Unknown 5, Completed 3, Terminated 1 |
| Phase 2 | 6 | Completed 6 |
| Not applicable | 1 | Completed 1 |
Follow fimasartan: new trials by email Literature Review of fimasartan trials Research Report on fimasartan
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia Fimasartan, Ezetimibe/Atorvastatin, Fimasartan Placebo - Essential Hypertension, Primary Hypercholesterolemia | Phase 3 | Completed | Boryung Pharmaceutical Co., Ltd | 148 | 2023-07-13 | 2024-10-18 |
| A Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy Fimasartan + Indapamide, Fimasartan + Indapamide placebo - Essential Hypertension | Phase 3 | Completed | Boryung Pharmaceutical Co., Ltd | 248 | 2022-11-09 | 2024-12-20 |
| A Study to Evaluate Drug-drug Interactions Between BR1017-1 and BR1017-2 in Healthy Volunteers BR1017-1, BR1017-2 - Hypertension, Hypercholesterinemia | Phase 1 | Completed | Boryung Pharmaceutical Co., Ltd | 32 | 2022-05-09 | 2023-02-08 |
| A Clinical Trial to Evaluate Drug-drug Interactions and Safety Between "BR1015-1" and "BR1015-2" in Healthy Volunteers BR1015-1, BR1015-2, BR1015-1 + BR1015-2 - Hypertension | Phase 1 | Completed | Boryung Pharmaceutical Co., Ltd | 31 | 2021-08-16 | 2021-11-22 |
| BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination Fimasartan/Amlodipine - Essential Hypertension | Phase 3 | Completed | Boryung Pharmaceutical Co., Ltd | 257 | 2019-06-17 | 2021-07-30 |
| A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Linagliptin in Healthy Volunteers Treatment A (Fimasartan, Linagliptin), Treatment B (Fimasartan/Linagliptin) - Hypertension, Diabetes | Phase 1 | Completed | Boryung Pharmaceutical Co., Ltd | 67 | 2018-07-18 | 2020-02-05 |
| A Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Atorvastatin in Patients With Essential Hypertension and Dyslipidemia Fimasartan 120mg, Atorvastatin 40mg, Placebo for Fimasartan 120mg - Essential Hypertension, Dyslipidemia | Phase 3 | Completed | Boryung Pharmaceutical Co., Ltd | 133 | 2018-01-15 | 2019-11-05 |
| Effect of Fimasartan on Extended RAS and Vascular Functions in Patients With Type 2 Diabetes and Hypertension Fimasartan - Hypertension, Atherosclerosis | Phase 4 | Unknown | Seoul National University Bundang Hospital | 42 | 2018-01-01 | 2023-08-14 |
| Drug Interaction Study of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects Fimasartan/Amlodipine combination drug, Hydrochlorothiazide - Drug-Drug Interaction | Phase 1 | Completed | Boryung Pharmaceutical Co., Ltd | 36 | 2017-12-15 | 2018-08-10 |
| Fimasartan Plus Amlodipine on Hemodynamic Parameters and Arterial Stiffness in Patients With Hypertension Fimasartan plus amlodipine besylate - Arterial Hypertension | Phase 4 | Unknown | Centro Universitario de Ciencias de la Salud, Mexico | 53 | 2017-09-01 | 2017-09-26 |
| A Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers (fimasartan or linagliptin) x 7days, (fimasartan and linagliptin) x 7days - Hypertension | Phase 1 | Completed | Boryung Pharmaceutical Co., Ltd | 39 | 2017-08-14 | 2018-01-18 |
| Combination of Fimasartan/Amlodipine/Rosuvastatin in Patients With Essential Hypertension and Dyslipidemia Fimasartan/Amlodipine, Rosuvastatin, Fimasartan/Amlodipine, Fimasartan, Rosuvastatin - Essential Hypertension, Dyslipidemia | Phase 3 | Completed | Boryung Pharmaceutical Co., Ltd | 138 | 2017-05-29 | 2019-06-10 |
| A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male Volunteers. Fimasartan, Atorvastatin - Hypertension, Hyperlipidemia | Phase 1 | Completed | Boryung Pharmaceutical Co., Ltd | 60 | 2016-12-23 | 2018-01-18 |
| A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Amlodipine in Healthy Male Subjects Fimasartan/Amlodipine, Fimasartan + Amlodipine - Hypertension | Phase 1 | Completed | Boryung Pharmaceutical Co., Ltd | 60 | 2016-10-01 | 2018-01-09 |
| A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin Fimasartan/Amlodipine combination drug, Rosuvastatin - Hypertension, Hyperlipidemia | Phase 1 | Completed | Boryung Pharmaceutical Co., Ltd | 60 | 2016-08-26 | 2017-08-10 |
| Fimasartan in the Senior Subjects Fimasartan or Fimasartan/Hydrochlorothiazide, Perindopril or Perindopril/Indapamide - The Elderly (≥ 70 Years) With Essential Hypertension | Phase 3 | Completed | Boryung Pharmaceutical Co., Ltd | 241 | 2016-07-15 | 2020-03-23 |
| A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects Fimasartan, Rosuvastatin, Fimasartan + Rosuvastatin - Hypertension | Phase 1 | Completed | Boryung Pharmaceutical Co., Ltd | 36 | 2016-03-01 | 2018-11-02 |
| A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin Fimasartan/Amlodipine/Rosuvastatin, Fimasartan/Amlodipine, Rosuvastatin - Hypertension, Hyperlipidemia | Phase 1 | Completed | Boryung Pharmaceutical Co., Ltd | 100 | 2015-09-01 | 2016-02-24 |
| A Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet Fimasartan/Atorvastatin Combination Tablet, Fimasartan, Atorvastatin - Hypertension, Hyperlipidemia | Phase 1 | Completed | Boryung Pharmaceutical Co., Ltd | 99 | 2015-08-01 | 2016-02-25 |
| Fimasartan Achieving SBP Target (FAST) Study Placebo, Fimasartan, Valsartan - Essential,Hypertension | Phase 4 | Completed | Boryung Pharmaceutical Co., Ltd | 369 | 2015-06-01 | 2017-07-05 |
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Hypertension (32) · Essential Hypertension (23) · Hyperlipidemias (4) · Dyslipidemias (3) · Diabetes Mellitus (2) · Aortic Valve Stenosis (1) · Atherosclerosis (1) · Coronary Artery Disease (1) · Diabetes Mellitus, Type 2 (1) · Hypertrophy, Left Ventricular (1) · Ischemic Stroke (1) · Lymphoma, Follicular (1) · Motor Activity (1) · Renal Insufficiency (1)
Boryung Pharmaceutical Co., Ltd (50) · Seoul National University Bundang Hospital (2) · Seoul National University Hospital (2) · Ajou University School of Medicine (1) · Asan Medical Center (1) · Centro Universitario de Ciencias de la Salud, Mexico (1) · Chuncheon Sacred Heart Hospital (1) · R-Pharm (1) · Seung-Jung Park (1) · Stendhal Americas, S.A. (1)
South Korea (40) · Mexico (1) · Russia (1)
E Engmann, MB ChB (2) · Kyung-Sang Yu, MD (2) · An-Hye Kim (1) · An-Hye Kim, M.D. Ph.D (1) · Byung-He Oh, Professor (1) · Byung-He Oh, professor (1) · Byung-Hee Oh, MD (1) · Byung-Hee Oh, Professor (1) · Cheol Ho Kim, Ph.D. (1) · Dong-Ju Choi, Professor (1) · Dong-Soo Kim, Professor (1) · Dongjoo Oh (1) · Duk-Hyun Kang, MD, PhD (1) · Eun-Suk Jeon, Professor (1)
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