Skip to main content
OpenTrials
Completed

NCT Number: NCT02620306

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Severance hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female adults aged 19 years or older
  • 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
  • eGFR: ≥ 30 ml/min/1.73 m2 within the past 6 months
  • 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.
  • Patients with diabetes
  • Voluntarily provided a written consent to participate
  • Able to understand this study, be cooperative in the execution of the study

Exclusion criteria

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

Treatment and study plan

Fimsartan 60mg~120mg

Drug

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.

Losartan 50mg~100mg

Drug

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.

Primary outcomes

  1. To compare and evaluate the rate of change in albuminuria

    Time frame: 6months

Secondary outcomes

  1. The time to the first occurrence of the cardiovascular composite endpoint in accordance with the blood pressure control criteria

    Time frame: 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

  2. The time to the first occurrence of the renal composite endpoint in accordance with the blood pressure control criteria

    Time frame: 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

  3. The time to the first occurrence of the combined cardiovascular and renal composite endpoint in accordance with the blood pressure control criteria

    Time frame: 36months

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2022
First posted
Dec 3, 2015
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.