Completed
FIESTAA Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Atorvastatin in Patients With Essential Hypertension and Dyslipidemia
What is being tested
Fimasartan 120mg
+ Placebo for Atorvastatin 40mg
+ Atorvastatin 40mg
Drug
Who is being recruted
Essential Hypertension+5
+ Cardiovascular Diseases
+ Hypertension
From 19 to 70 Years
+14 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: January 2018
Summary
Principal SponsorBoryung Pharmaceutical Co., Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 15, 2018
Actual date on which the first participant was enrolled.The objective of this clinical study is to evaluate the efficacy and safety by comparing the fimasartan/atorvastatin treatment group to the fimasartan/placebo treatment group and the placebo/atorvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia.
Official TitleA Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Atorvastatin in Patients With Essential Hypertension and Dyslipidemia
Principal SponsorBoryung Pharmaceutical Co., Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
133 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 19 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Essential HypertensionCardiovascular DiseasesHypertensionMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesDyslipidemiasLipid Metabolism Disorders
Criteria
5 inclusion criteria required to participate
Voluntarily provided a written consent to participate in this clinical study
Male or female adults aged 19-70 years
Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (V1)
Uncontrolled blood pressure (140 mmHg ≤ mean SiSBP < 180 mmHg) at the pre- baseline visit (V2) after wash-out period
Show More Criteria
9 exclusion criteria prevent from participating
Severe hypertension with mean Sitting systolic blood pressure(SiSBP)≥180 mmHg or Sitting diastolic blood pressure(SiDBP) ≥110 mmHg at the screening visit (V1) and the pre-baseline visit (V2), or orthostatic hypotension accompanied by symptoms
Difference of Sitting systolic blood pressure(SiSBP) ≥ 20 mmHg and Sitting diastolic blood pressure(SiDBP) ≥ 10 mmHg between Lt and Rt arms for 3 consecutive times at the screening visit (V1)
Secondary hypertension patients: Secondary hypertension is not limited to the following diseases; (e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney disease)
Uncontrolled diabetes mellitus (currently on insulin, or HbA1c >9% at the pre-baseline visit (V2)), or uncontrolled hypothyroidism (TSH ≥1.5 times the upper limit at the pre-baseline visit (V2))
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorCo-administration of Fimasartan 120mg and Placebo for Atorvastatin 40mg
Group II
ExperimentalCo-administration of a fixed dose combination of Fimasartan 120mg and Atorvastatin 40mg
Group III
Active ComparatorCo-administration of Atorvastatin 40mg and Placebo for Fimasartan 120mg
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center