NCT03246555

Fimasartan in the Senior Subjects

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• The Elderly (≥ 70 Years) With Essential Hypertension

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-07-15
• Primary completion: 2019-08-19
• Completion: 2019-12-09
• First posted: 2017-08-11
• Last updated: 2020-03-23

Locations

1 site across 1 country: South Korea