NCT02495324

Fimasartan Achieving SBP Target (FAST) Study

A Randomized, Double-blind, Active Control, 3-parallel Group, Forced Titration, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Fimasartan Versus Valsartan Monotherapy in Patients With Mild to Moderate Essential Hypertension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 369 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Fimasartan compared to Valsartan and Olmesartan(reference group) in patients with mild to moderate essential hypertension. Patients have 2 weeks of placebo run-in and wash out period, 2 weeks of taking required dose and 4 weeks of taking double dose.

Detailed description

A randomized, double-blind, active control, 3-parallel group comparison clinical study to evaluate the anti-hypertensive efficacy and safety of Fimasartan in patients with mild to moderate hypertension. Approximately 360 patients will be enrolled in 8 centers in South Korea. This study has planned 6 visits during 8 weeks.(2 weeks of placebo run-in and wash out, 2 weeks of treatment and 4 weeks of forced titration) All of the subjects who agreed to participate in this study and gave written informed consent voluntarily are assessed the inclusion and exclusion criteria and receive the investigational product(placebo) at screening visit. During more than 14 days of placebo run-in and wash out period, subjects have to stop the previous anti-hypertensive drug. After placebo run-in and wash out period, Subjects are assessed the final eligibility and started measuring ambulatory blood pressure for 24 hours. Subjects who determined to be appropriate for this study are allocated to experimental group(Fimasartan 60mg) or control group(Valsartan 80mg) or Reference group(Olmesartan 10mg) randomly at ratio 3:3:1.Subjects take their investigational products daily for 2 weeks and double dose for 4 weeks. The placebo period will be single-blinded and the treatment allocation in this study will be double-blinded.

Conditions

• Essential,Hypertension

Interventions

Type	Name	Description
DRUG	Placebo	2 weeks of placebo PO daily
DRUG	Fimasartan	60mg 1 tab PO daily for 2 weeks and 120mg 1 tab PO daily for 4 weeks
DRUG	Valsartan	80mg 1 tab PO daily for 2 weeks and 160mg 1 tab PO daily for 4 weeks
DRUG	Olmesartan medoxomil	10mg 1 tab PO daily for 2 weeks and 20mg 1 tab PO daily for 4 weeks

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2015-07-13
• Last updated: 2017-07-05

Locations

8 sites across 1 country: South Korea