| Trial ID: | L0340 |
| Source ID: | NCT02620306
|
| Associated Drug: |
Fimsartan 60mg~120mg
|
| Title: |
A Randomized, Double-blind, Active Control, Parallel Group, Titration, Multicenter Study to Evaluate the Efficacy and Safety of Fimasartan
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: Fimsartan 60mg~120mg|DRUG: Fimsartan 60mg~120mg|DRUG: Losartan 50mg~100mg|DRUG: Losartan 50mg~100mg
|
| Outcome Measures: |
Primary: To compare and evaluate the rate of change in albuminuria, 6months | Secondary: 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|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
|
| Sponsor/Collaborators: |
Sponsor: Boryung Pharmaceutical Co., Ltd
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
351
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-02-11
|
| Completion Date: |
2022-05-11
|
| Results First Posted: |
|
| Last Update Posted: |
2022-05-25
|
| Locations: |
Severance hospital, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT02620306
|
