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

Essential Hypertension, Dyslipidemia Clinical Trial

— FIESTA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338426
• Other study ID #: BR-FAVC-CT-301
• Status: Completed
• Phase: Phase 3
• Start date: January 15, 2018
• Est. completion date: April 22, 2019

Study information

• Verified date: October 2019
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: April 22, 2019
• Est. primary completion date: April 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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 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)

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

Related Conditions & MeSH terms

• Dyslipidemias
• Essential Hypertension
• Essential Hypertension, Dyslipidemia
• Hypertension

Intervention

Drug:
• Fimasartan 120mg
Fimasartan 120mg will be administrated once daily for 8 weeks treatment period
• Atorvastatin 40mg
Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period
• Placebo for Fimasartan 120mg
Placebo for Fimasartan 120mg will be administrated once daily for 8 weeks treatment period
• Placebo for Atorvastatin 40mg
Placebo for Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SiSBP	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)	8weeks from Baseline Visit
Primary	LDL-C	The change in LDL-C from baseline in the test group at Week 8 compared to the active comparator group 1(fimasartan 120 mg)	8weeks from Baseline Visit
Secondary	SiSBP	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)	8weeks from Baseline Visit
Secondary	LDL-C	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)	8weeks from Baseline Visit