ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02620306
Recruitment Status : Recruiting
First Posted : December 3, 2015
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

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

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Fimsartan 60mg~120mg Drug: Losartan 50mg~100mg Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : November 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Losartan

Arm Intervention/treatment
Experimental: Fimasartan(A) 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.

Experimental: Fimasartan(B) 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.

Active Comparator: Losartan(A) 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.

Active Comparator: Losartan(B) 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.




Primary Outcome Measures :
  1. To compare and evaluate the rate of change in albuminuria [ Time Frame: 6months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620306


Locations
Korea, Republic of
Severance hospital Recruiting
Seoul, Korea, Republic of
Contact: Sungha Park    02-2228-8455    shpark0530@yuhs.ac   
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT02620306     History of Changes
Other Study ID Numbers: BR-FMS-CT-303
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action