Fimasartan in the Senior Subjects

Phase 3

Completed

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

• Registration Number: NCT03246555
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-15
• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-11
• Primary Completion: 2019-08-19
• Study Completion: 2019-12-09
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-19
• Last Update Posted: 2020-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perindopril or Perindopril/Indapamide	Perindopril or Perindopril/Indapamide	-
Fimasartan or Fimasartan/Hydrochlorothiazide	Fimasartan or Fimasartan/Hydrochlorothiazide	-

Primary Outcome Measures

Name	Time	Method
Change in siSBP	8 weeks	Change in siSBP from baseline after the administration of the investigational product for 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in siSBP	Weeks 4, 16 and 24	Change in siSBP from baseline at Weeks 4, 16 and 24
Change in siDBP	Weeks 4, 8, 16 and 24	Change in siDBP from baseline at Weeks 4, 8, 16 and 24
Blood pressure response rate	4, 8 and 16 weeks	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)
Change from baseline in the differences in standing SBP and DBP compared to their sitting measurements	4, 8, 16 and 24 weeks	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

Trial Locations

Locations (1)

Seoul National University Bundang; 🇰🇷 Seoul, Korea, Republic of