Fimasartan in the Senior Subjects (FITNESS)

A Randomized, Double-blind, Active-controlled, 2-parallel Group, Optional Titration, Multicenter, Phase 3b Study to Evaluate the Efficacy and Safety of Fimasartan Versus Perindopril Monotherapy With and Without Diuretics Combination in Elderly Patients With Essential Hypertension

The objective of this study is to confirm the noninferiority of the blood pressure lowering effect of fimasartan and evaluate its safety compared to perindopril in the elderly with essential hypertension.

Study Overview

• Status: Completed
• Conditions: The Elderly (≥ 70 Years) With Essential Hypertension
• Intervention / Treatment: Drug: Fimasartan or Fimasartan/Hydrochlorothiazide; Drug: Perindopril or Perindopril/Indapamide

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Bundang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Voluntarily provided a written consent to participate in this clinical study after receiving an explanation of this study
2. Elderly aged 70 years or older

3. At the screening visit (Visit 1), Blood pressure: Mean blood pressure measured 3 times on the selected arm is as below.

   • For treatment-naïve patients who have not taken drugs for hypertension within the last 3 months from the screening visit: Mean siSBP ≥ 140mmHg
   • For patients with essential hypertension who are taking drugs for hypertension: Mean siSBP ≥ 130mmHg
4. At the baseline visit (Visit 2), Blood pressure: Patients with mild to moderate essential hypertension whose mean siSBP measured 3 times on the selected arm is ≥140 mmHg Patients with treatment compliance of ≥70% during the placebo run-in period
5. Capable of understanding written instructions, cooperative, able to participate until the end of the clinical study

Exclusion Criteria:

1. Severe hypertension patients with mean siSBP ≥ 180 mmHg or siDBP ≥ 110 mmHg (office BP) at the screening visit (Visit 1) and the baseline visit (Visit 2) (However, at screening, it is based on the blood pressures measured from both arms, and the patient is excluded if the result from any of the arms falls within the criteria.)
2. Patients with siSBP ≥ 20 mmHg and siDBP ≥ 10 mmHg in the difference between blood pressures in the selected arm at the screening visit (Visit 1)
3. Patients with a history of secondary hypertension and any history suspected of secondary hypertension (but not limited to the following: coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, etc.)
4. Orthostatic hypotension with symptoms
5. Patients with insulin-dependent diabetes mellitus or uncontrolled diabetes mellitus (HbA1c > 9.0% at the screening visit (Visit 1))
6. Patients with a history of malignant tumor, including leukemia and lymphoma, within the past 5 years (however, participation is allowed if it has not recurred for at least 5 years after a tumor surgery)
7. Patients with any chronic inflammatory disease requiring chronic anti-inflammatory treatment, consumption disease, autoimmune disease like rheumatoid arthritis and systemic lupus erythematosus, etc., or connective tissue disease at present or in the past
8. Patients with a history of hypersensitivity reaction to any component of the investigational product and its similar compound Renin-angiotensin system inhibitors, ACE inhibitors, thiazide diuretics and sulfonamides, Yellow 5 (Sunset Yellow FCF), etc.
9. Patients with hyperlipidemia undergoing LDL (low density lipoprotein) apheresis (patients undergoing LDL hemapheresis using a dextran sulfate cellulose)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fimasartan or Fimasartan/Hydrochlorothiazide	Drug: Fimasartan or Fimasartan/Hydrochlorothiazide; The treatment in this clinical study starts with fimasartan 30 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.
Active Comparator: Perindopril or Perindopril/Indapamide	Drug: Perindopril or Perindopril/Indapamide; The treatment in this clinical study starts with penrindopril 2.5 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in siSBP	Change in siSBP from baseline after the administration of the investigational product for 8 weeks	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in siSBP	Change in siSBP from baseline at Weeks 4, 16 and 24	Weeks 4, 16 and 24
Change in siDBP	Change in siDBP from baseline at Weeks 4, 8, 16 and 24	Weeks 4, 8, 16 and 24
Blood pressure response rate	Blood pressure response rate (siSBP < 140 mmHg, or decrease of △siSBP ≥ 20 mmHg after the administration for 4, 8 and 16 weeks compared to baseline) and blood pressure normalization rate after the administration of the investigational products for 4, 8 and 16 weeks(siSBP<140mmHg and siDBP<90mmHg)	4, 8 and 16 weeks
Change from baseline in the differences in standing SBP and DBP compared to their sitting measurements	Change from baseline in the differences in standing SBP and DBP compared to their sitting measurements after the administration of the investigational product for 4, 8, 16 and 24 weeks	4, 8, 16 and 24 weeks

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd

Publications and helpful links

General Publications

• Lee HY, Kim KI, Ihm SH, Rhee MY, Sohn IS, Park S, Jeon ES, Song JM, Pyun WB, Sung KC, Kim MH, Kim SH, Kim SY, Kim SJ, Kim EJ, Shin J, Lee SY, Chun KJ, Jeong JO, Chae SC, Yoo KD, Choi YJ, Park YH, Kim CH. A Randomized, Double-blind, Active-controlled, Two Parallel-Group, Optional Titration, Multicenter, Phase IIIb Study to Evaluate the Efficacy and Safety of Fimasartan Versus Perindopril Monotherapy With and Without a Diuretic Combination in Elderly Patients With Essential Hypertension. Clin Ther. 2021 Oct;43(10):1746-1756. doi: 10.1016/j.clinthera.2021.08.003. Epub 2021 Sep 7.
• Kang MG, Kim KI, Ihm SH, Rhee MY, Sohn IS, Lee HY, Park S, Jeon ES, Song JM, Pyun WB, Sung KC, Kim MH, Kim SH, Kim SY, Kim SJ, Kim EJ, Shin J, Lee SY, Chun KJ, Jeong JO, Chae SC, Yoo KD, Choi YJ, Park YH, Kim CH. Fimasartan versus perindopril with and without diuretics in the treatment of elderly patients with essential hypertension (Fimasartan in the Senior Subjects (FITNESS)): study protocol for a randomized controlled trial. Trials. 2019 Jul 1;20(1):389. doi: 10.1186/s13063-019-3466-5.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2016
• Primary Completion (Actual): August 19, 2019
• Study Completion (Actual): December 9, 2019

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin-Converting Enzyme Inhibitors; Sodium Chloride Symporter Inhibitors; Hydrochlorothiazide; Perindopril; Indapamide
• Other Study ID Numbers: BR-FMS-CT-304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No