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The purpose of this study is to evaluate the Efficacy and Safety of Fimasartan in patients with hypertensive diabetic chronic kidney disease.
The randomized subjects will take the investigational product (Fimasartan or Losartan) corresponding to each treatment group for 24 weeks. After that, all subjects will take Fimasartan for additional 120 weeks in an open-label, 2-parallel group study conducted with 2 groups in accordance with the blood pressure control criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fimasartan(A) | Experimental |
| |
| Fimasartan(B) | Experimental |
| |
| Losartan(A) | Active Comparator |
| |
| Losartan(B) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimsartan 60mg~120mg | Drug | Standard BP control group (SBP < 140 mmHg). In case of patients with blood pressure that cannot be controlled to the targeted level during the entire clinical study period, the dose of study drug is increased or other antihypertensive drugs are administered concomitantly. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare and evaluate the rate of change in albuminuria | 6months |
| Measure | Description | Time Frame |
|---|---|---|
| The time to the first occurrence of the cardiovascular composite endpoint in accordance with the blood pressure control criteria | Cardiovascular composite endpoint: Occurrence of myocardial infarction (MI) and stroke; hospitalization due to heart failure and unstable angina; coronary revascularization and peripheral revascularization; and all caused death | 36months |
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Inclusion Criteria:
Male and female adults aged 19 years or older
Blood pressure: Mean blood pressure is as below at screening.
eGFR: ≥ 30 ml/min/1.73 m2 within the past 6 months
Albuminuria (ACR) excretion volume: Meets one or more of the following conditions
Patients with diabetes
Voluntarily provided a written consent to participate
Able to understand this study, be cooperative in the execution of the study
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39085979 | Derived | Park CH, Hong SJ, Kim SG, Shin SJ, Kim DK, Lee JP, Han SY, Lee S, Won JC, Kang YS, Park J, Han BG, Na KR, Hur KY, Kim YJ, Park S, Yoo TH. Blood pressure control in diabetic kidney disease: a post-hoc analysis of the FANTASTIC trial. Clin Hypertens. 2024 Aug 1;30(1):20. doi: 10.1186/s40885-024-00280-x. | |
| 38682786 | Derived |
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|
| Fimsartan 60mg~120mg | Drug | Strict BP control group (SBP < 130 mmHg). In case of patients with blood pressure that cannot be controlled to the targeted level at each visit during the entire clinical study period, the dose of study drug is increased or other antihypertensive drugs are administered concomitantly. |
|
| Losartan 50mg~100mg | Drug | Standard BP control group (SBP < 140 mmHg). In case of patients with blood pressure that cannot be controlled to the targeted level during the entire clinical study period, the dose of study drug is increased or other antihypertensive drugs are administered concomitantly. |
|
| Losartan 50mg~100mg | Drug | Strict BP control group (SBP < 130 mmHg). In case of patients with blood pressure that cannot be controlled to the targeted level at each visit during the entire clinical study period, the dose of study drug is increased or other antihypertensive drugs are administered concomitantly. |
|
| The time to the first occurrence of the renal composite endpoint in accordance with the blood pressure control criteria | Renal composite endpoint: The time point where the reduction in eGFR of ≥ 50% compared with baseline eGFR; the time where the progression to ESRD is confirmed (in case of the initiation of long-term dialysis or renal transplantation); all caused death | 36months |
| The time to the first occurrence of the combined cardiovascular and renal composite endpoint in accordance with the blood pressure control criteria | 36months |
| Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2. |
| 29284530 | Derived | Kim JY, Son JW, Park S, Yoo TH, Kim YJ, Ryu DR, Chin HJ. FimAsartaN proTeinuriA SusTaIned reduCtion in comparison with losartan in diabetic chronic kidney disease (FANTASTIC): study protocol for randomized controlled trial. Trials. 2017 Dec 29;18(1):632. doi: 10.1186/s13063-017-2375-8. |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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