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CompletedNCT02620306Updated May 25, 2022

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

A Phase 3 interventional study of Fimsartan 60mg~120mg and Fimsartan 60mg~120mg in Chronic Kidney Disease, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-05-25.

Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
351
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Chronic Kidney Disease
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 351 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 139 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
351 participants (actual)

Study arms

  • Experimental
    Fimasartan(A)

    Drug: Fimsartan 60mg~120mg

  • Experimental
    Fimasartan(B)

    Drug: Fimsartan 60mg~120mg

  • Active comparator
    Losartan(A)

    Drug: Losartan 50mg~100mg

  • Active comparator
    Losartan(B)

    Drug: Losartan 50mg~100mg

Interventions

  • DrugFimsartan 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.

  • DrugFimsartan 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.

  • DrugLosartan 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.

  • DrugLosartan 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.

06

What researchers measure

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

    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

    Time frame: 36months

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

    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

    Time frame: 36months

  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

07

Study locations

1 site
  • Severance hospital
    Seoul, Korea, Republic of
08

References and documents

Publications

  • Kim JY, Son JW, Park S, Yoo TH, Kim YJ, Ryu DR, Chin HJ. FimAsartaN proTeinuriA SusTaIned reduCtion in comparison with losartan in diabetic chronic kidney disease (FANTASTIC): study protocol for randomized controlled trial. Trials. 2017 Dec 29;18(1):632. doi: 10.1186/s13063-017-2375-8. PubMed 29284530 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02620306
Lead sponsor
Boryung Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Dec 3, 2015
Start date
Feb 11, 2016
Primary completion
Dec 23, 2019
Completion
May 11, 2022
Last update
May 25, 2022
View the source record on ClinicalTrials.gov ↗

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