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

Boryung

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease

Treatments: Drug: Losartan 50mg~100mg; Drug: Fimsartan 60mg~120mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02620306

BR-FMS-CT-303

Details and patient eligibility

About

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

Full 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.

Enrollment: 351 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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351 participants in 4 patient groups

Fimasartan(A)

Experimental group

Treatment:

Drug: Fimsartan 60mg~120mg

Drug: Fimsartan 60mg~120mg

Fimasartan(B)

Experimental group

Treatment:

Drug: Fimsartan 60mg~120mg

Drug: Fimsartan 60mg~120mg

Losartan(A)

Active Comparator group

Treatment:

Drug: Losartan 50mg~100mg

Drug: Losartan 50mg~100mg

Losartan(B)

Active Comparator group

Treatment:

Drug: Losartan 50mg~100mg

Drug: Losartan 50mg~100mg