Clinical trial NCT02620306: A Randomized, Double-blind, Active Control, Parallel Group, Titration, Multicenter Study to Evaluate the Efficacy and Safety of Fimasartan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2015-12-03
Enrollment: 351
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare and evaluate the rate of change in albuminuria
timeFrame: 6months
Secondary outcomes:
measure: The time to the first occurrence of the cardiovascular composite endpoint in accordance with the blood pressure control criteria
timeFrame: 36months
measure: The time to the first occurrence of the renal composite endpoint in accordance with the blood pressure control criteria
timeFrame: 36months
measure: The time to the first occurrence of the combined cardiovascular and renal composite endpoint in accordance with the blood pressure control criteria
timeFrame: 36months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
citation: 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.