Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Atorvastatin in Patients With Essential Hypertension and Dyslipidemia
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
Essential Hypertension, Dyslipidemia
Eligibility:
All Genders
19-70 years
Phase:
PHASE3
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/atorvasta...
Eligibility Criteria
Inclusion
- 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
- Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion
Exclusion
- 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))
- 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.
- Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator
- Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant aortic valve stenosis or mitral valve stenosis
- Cerebrovascular disorder (stroke, cerebral infarction, transient cerebral ischemic attack, cerebral hemorrhage, etc. within 6 months prior to the screening visit (V1)
- Pregnant or lactating women
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2019
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT03338426
Start Date
January 15 2018
End Date
April 22 2019
Last Update
November 5 2019
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea