NCT02620306

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 351 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Fimsartan 60mg~120mg	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.
DRUG	Fimsartan 60mg~120mg	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.
DRUG	Losartan 50mg~100mg	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.
DRUG	Losartan 50mg~100mg	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.

Timeline

• Start date: 2016-02-11
• Primary completion: 2019-12-23
• Completion: 2022-05-11
• First posted: 2015-12-03
• Last updated: 2022-05-25

Locations

1 site across 1 country: South Korea