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A Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Atorvastatin in Patients With Essential Hypertension and Dyslipidemia (FIESTA)

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ClinicalTrials.gov Identifier: NCT03338426
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Essential Hypertension, Dyslipidemia Drug: Fimasartan 120mg Drug: Atorvastatin 40mg Drug: Placebo for Fimasartan 120mg Drug: Placebo for Atorvastatin 40mg Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 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
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
Co-administration of a fixed dose combination of Fimasartan 120mg and Atorvastatin 40mg
Drug: Fimasartan 120mg
Fimasartan 120mg will be administrated once daily for 8 weeks treatment period

Drug: Atorvastatin 40mg
Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period

Active Comparator: Active Comparator 1
Co-administration of Fimasartan 120mg and Placebo for Atorvastatin 40mg
Drug: Fimasartan 120mg
Fimasartan 120mg will be administrated once daily for 8 weeks treatment period

Drug: Placebo for Atorvastatin 40mg
Placebo for Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period

Active Comparator: Active Comparator 2
Co-administration of Atorvastatin 40mg and Placebo for Fimasartan 120mg
Drug: Atorvastatin 40mg
Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period

Drug: Placebo for Fimasartan 120mg
Placebo for Fimasartan 120mg will be administrated once daily for 8 weeks treatment period




Primary Outcome Measures :
  1. SiSBP [ Time Frame: 8weeks from Baseline Visit ]
    The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 2(Atorvastatin 40mg)

  2. LDL-C [ Time Frame: 8weeks from Baseline Visit ]
    The change in LDL-C from baseline in the test group at Week 8 compared to the active comparator group 1(fimasartan 120 mg)


Secondary Outcome Measures :
  1. SiSBP [ Time Frame: 8weeks from Baseline Visit ]
    The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 1(Fimasartan 120mg)

  2. LDL-C [ Time Frame: 8weeks from Baseline Visit ]
    The change in LDL-C from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 2(Atorvastatin 40mg)



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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Voluntarily provided a written consent to participate in this clinical study
  2. Male or female adults aged 19-70 years
  3. Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (V1)
  4. Uncontrolled blood pressure (140 mmHg ≤ mean SiSBP < 180 mmHg) at the pre- baseline visit (V2) after wash-out period
  5. Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion

Exclusion Criteria:

  1. 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
  2. Difference of mean Sitting systolic blood pressure(SiSBP) ≥ 20 mmHg and Sitting diastolic blood pressure(SiDBP) ≥ 10 mmHg between Lt and Rt arms at the screening visit (V1)
  3. 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)
  4. 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))
  5. Heart disease (heart failure of New York Heart Association (NYHA) class 3 and 4), or ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular diseasenewly diagnosed within 6 months prior to the screening visit (V1), percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc.
  6. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator
  7. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant aortic valve stenosis or mitral valve stenosis
  8. Cerebrovascular disorder (stroke, cerebral infarction, transient cerebral ischemic attack, cerebral hemorrhage, etc. within 6 months prior to the screening visit (V1)
  9. Pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338426


Contacts
Contact: Jae-Jin Nah 82-2-708-8000 jj.nah@boryung.co.kr

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seok-min Kang, M.D., Ph.D.         
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd

Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT03338426     History of Changes
Other Study ID Numbers: BR-FAVC-CT-301
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors