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

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Treatments: Losartan

Criteria

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