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

Boryung Pharmaceutical Co., Ltd1 site in 1 country241 target enrollmentJuly 15, 2016

ConditionsThe Elderly (≥ 70 Years) With Essential Hypertension

InterventionsFimasartan or Fimasartan/Hydrochlorothiazide Perindopril or Perindopril/Indapamide

DrugsFimasartan or Fimasartan/Hydrochlorothiazide Perindopril or Perindopril/Indapamide

Overview

Phase: Phase 3
Intervention: Fimasartan or Fimasartan/Hydrochlorothiazide
Conditions: The Elderly (≥ 70 Years) With Essential Hypertension
Sponsor: Boryung Pharmaceutical Co., Ltd
Enrollment: 241
Locations: 1
Primary Endpoint: Change in siSBP
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 15, 2016

End Date

December 9, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boryung Pharmaceutical Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily provided a written consent to participate in this clinical study after receiving an explanation of this study
•Elderly aged 70 years or older
•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
•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
•Capable of understanding written instructions, cooperative, able to participate until the end of the clinical study

Exclusion Criteria

•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.)
•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)
•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.)
•Orthostatic hypotension with symptoms
•Patients with insulin-dependent diabetes mellitus or uncontrolled diabetes mellitus (HbA1c \> 9.0% at the screening visit (Visit 1))
•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)
•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
•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.
•Patients with hyperlipidemia undergoing LDL (low density lipoprotein) apheresis (patients undergoing LDL hemapheresis using a dextran sulfate cellulose)

Arms & Interventions

Fimasartan or Fimasartan/Hydrochlorothiazide

Intervention: Fimasartan or Fimasartan/Hydrochlorothiazide

Perindopril or Perindopril/Indapamide

Intervention: Perindopril or Perindopril/Indapamide

Outcomes

Primary Outcomes

Change in siSBP

Time Frame: 8 weeks

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

Secondary Outcomes

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