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FITNESS: Fimasartan vs Perindopril in Elderly Hypertension

NCT03246555Phase 3

Key facts

Status: Completed
Start: Jul 2016
Primary completion: Aug 2019
Countries: 1
Sponsor: Boryung
Modality: Small Molecules

Drugs: fimasartan
Conditions: essential hypertension

Overview

Phase 3, randomised, double-blind trial of fimasartan in essential hypertension (2 arms), sponsored by Boryung. Primary endpoint: Change in Sitting Systolic Blood Pressure at 8 weeks. Started Jul 2016; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Fimasartan Arm
Fimasartan 30mg -> 60mg -> 60mg/HCTZ
Perindopril Arm
Perindopril 2.5mg -> 5mg -> 5mg/Indapamide

Who it enrols

Elderly patients (>= 70 years) with mild to moderate essential hypertension (siSBP >= 140 mmHg). Patients with severe hypertension, secondary hypertension, or uncontrolled diabetes are excluded.

Endpoints

Primary

Change in Sitting Systolic Blood Pressure8 weeks

Secondary

Change in Sitting Systolic Blood Pressure24 weeks
Change in Sitting Diastolic Blood Pressure24 weeks
Blood Pressure Response Rate16 weeks
Change in Standing vs Sitting Blood Pressure Difference24 weeks

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