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

NCT02620306 | Completed Phase 3

• 1 other identifier: BR-FMS-CT-303
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• To compare and evaluate the rate of change in albuminuria

  6months

Secondary Outcomes (3)

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

  36months

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

  36months

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

  36months

Study Arms (4)

Fimasartan(A)

EXPERIMENTAL

Drug: Fimsartan 60mg~120mg

Fimasartan(B)

EXPERIMENTAL

Drug: Fimsartan 60mg~120mg

Losartan(A)

ACTIVE COMPARATOR

Drug: Losartan 50mg~100mg

Losartan(B)

ACTIVE COMPARATOR

Drug: Losartan 50mg~100mg

Interventions

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.

Fimasartan(A)

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.

Losartan(A)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Severance hospital

Seoul, South Korea

Location

Related Publications (3)

• Park CH, Hong SJ, Kim SG, Shin SJ, Kim DK, Lee JP, Han SY, Lee S, Won JC, Kang YS, Park J, Han BG, Na KR, Hur KY, Kim YJ, Park S, Yoo TH. Blood pressure control in diabetic kidney disease: a post-hoc analysis of the FANTASTIC trial. Clin Hypertens. 2024 Aug 1;30(1):20. doi: 10.1186/s40885-024-00280-x.

  PMID: 39085979 DERIVED

• Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.

  PMID: 38682786 DERIVED

• 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.

  PMID: 29284530 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 3, 2015
• Study Start: February 11, 2016
• Primary Completion: December 23, 2019
• Study Completion: May 11, 2022
• Last Updated: May 25, 2022

Record last verified: 2021-05

Locations

KR (1)