A Randomized, Double-blind, Active Control, Parallel Group, Titration, Multicenter Study to Evaluate the Efficacy and Safety of Fimasartan

Phase 3

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Fimsartan 60mg~120mg; Drug: Losartan 50mg~100mg

• Registration Number: NCT02620306
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

The purpose of this study is to evaluate the Efficacy and Safety of Fimasartan in patients with hypertensive diabetic chronic kidney disease.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-03
• Study Start: 2016-02-11
• Primary Completion: 2019-12-23
• Status Verified: 2021-05
• Study Completion: 2022-05-11
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

Inclusion Criteria

1. Male and female adults aged 19 years or older

2. Blood pressure: Mean blood pressure is as below at screening.

   • For treatment-naïve patients: 140 mmHg ≤ SBP < 180 mmHg and DBP < 110 mmHg
   • For patients who are taking ACEI or ARB: 130 mmHg ≤ SBP < 180 mmHg and DBP < 110 mmHg

3. eGFR: ≥ 30 ml/min/1.73 m2 within the past 6 months

4. Albuminuria (ACR) excretion volume: Meets one or more of the following conditions

   • ACR > 300 mg/g (or mg/day) within the past 12 months
   • There are at least two results of 30 ≤ ACR ≤ 300 mg/g (or mg/day) within the past 12 months and the interval between the two test is at least 12 weeks.

5. Patients with diabetes

6. Voluntarily provided a written consent to participate

7. Able to understand this study, be cooperative in the execution of the study

Exclusion Criteria

1. Severe hypertension with mean SBP ≥ 180 mmHg or DBP ≥ 110 mmHg
2. Orthostatic hypotension with symptoms
3. Insulin dependent diabetes mellitus or uncontrolled diabetes mellitus
4. Patients on dialysis, patients with clinically significant cardiac and hepatic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fimasartan(A)	Fimsartan 60mg~120mg	-
Losartan(A)	Losartan 50mg~100mg	-
Fimasartan(B)	Fimsartan 60mg~120mg	-
Losartan(B)	Losartan 50mg~100mg	-

Primary Outcome Measures

Name	Time	Method
To compare and evaluate the rate of change in albuminuria	6months

Secondary Outcome Measures

Name	Time	Method
The time to the first occurrence of the renal composite endpoint in accordance with the blood pressure control criteria	36months	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
The time to the first occurrence of the cardiovascular composite endpoint in accordance with the blood pressure control criteria	36months	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
The time to the first occurrence of the combined cardiovascular and renal composite endpoint in accordance with the blood pressure control criteria	36months

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of