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

NCT ID: NCT03338426

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2019-04-22

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.

Conditions

Essential Hypertension, Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental

Co-administration of a fixed dose combination of Fimasartan 120mg and Atorvastatin 40mg

Group Type: EXPERIMENTAL

Fimasartan 120mg

Intervention Type: DRUG

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

Atorvastatin 40mg

Intervention Type: DRUG

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

Active Comparator 1

Co-administration of Fimasartan 120mg and Placebo for Atorvastatin 40mg

Group Type: ACTIVE_COMPARATOR

Fimasartan 120mg

Intervention Type: DRUG

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

Placebo for Atorvastatin 40mg

Intervention Type: DRUG

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

Active Comparator 2

Co-administration of Atorvastatin 40mg and Placebo for Fimasartan 120mg

Group Type: ACTIVE_COMPARATOR

Atorvastatin 40mg

Intervention Type: DRUG

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

Placebo for Fimasartan 120mg

Intervention Type: DRUG

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

Interventions

Fimasartan 120mg

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

Intervention Type: DRUG

Atorvastatin 40mg

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

Intervention Type: DRUG

Placebo for Fimasartan 120mg

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

Intervention Type: DRUG

Placebo for Atorvastatin 40mg

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

Intervention Type: DRUG

Eligibility 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 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BR-FAVC-CT-301

Identifier Type: -

Identifier Source: org_study_id