Fimasartan in the Senior Subjects (FITNESS)

Boryung

Status and phase: Completed; Phase 3

Conditions: The Elderly (≥ 70 Years) With Essential Hypertension

Treatments: Drug: Perindopril or Perindopril/Indapamide; Drug: Fimasartan or Fimasartan/Hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03246555

BR-FMS-CT-304

Details and patient eligibility

About

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.

Enrollment: 241 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

241 participants in 2 patient groups

Fimasartan or Fimasartan/Hydrochlorothiazide

Experimental group

Treatment:

Drug: Fimasartan or Fimasartan/Hydrochlorothiazide

Perindopril or Perindopril/Indapamide

Active Comparator group

Treatment:

Drug: Perindopril or Perindopril/Indapamide