NCT03156842

Combination of Fimasartan/Amlodipine/Rosuvastatin in Patients With Essential Hypertension and Dyslipidemia

A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Amlodipine/Rosuvastatin in Patients With Essential Hypertension and Dyslipidemia Who Fail to Respond Adequately to Fimasartan Monotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical study is to evaluate the efficacy and safety by comparing the fimasartan/amlodipine/rosuvastatin treatment group to the fimasartan/amlodipine treatment group and the fimasartan/rosuvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia who fail to respond to the fimasartan monotherapy.

Conditions

• Essential Hypertension
• Dyslipidemia

Interventions

Type	Name	Description
DRUG	Fimasartan/Amlodipine, Rosuvastatin	"A fixed dose combination tablet of Fimasartan and Amlodipine" and "Rosuvastatin" will be administrated once daily on treatment period.
DRUG	Fimasartan/Amlodipine	"A fixed dose combination tablet of Fimasartan and Amlodipine" will be administrated once daily on treatment period.
DRUG	Fimasartan, Rosuvastatin	"Fimasartan" and "Rosuvastatin" will be administrated once daily on treatment period.

Timeline

• Start date: 2017-05-29
• Primary completion: 2018-12-07
• Completion: 2018-12-07
• First posted: 2017-05-17
• Last updated: 2019-06-10

Locations

1 site across 1 country: South Korea