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

NCT03338426 | Completed Phase 3

• 1 other identifier: BR-FAVC-CT-301
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• SiSBP

  8weeks from Baseline Visit

• LDL-C

  8weeks from Baseline Visit

Study Arms (3)

Experimental

EXPERIMENTAL

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

Drug: Fimasartan 120mg; Drug: Atorvastatin 40mg

Active Comparator 1

ACTIVE COMPARATOR

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

Drug: Fimasartan 120mg; Drug: Placebo for Atorvastatin 40mg

Active Comparator 2

ACTIVE COMPARATOR

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

Drug: Atorvastatin 40mg; Drug: Placebo for Fimasartan 120mg

Interventions

Fimasartan 120mg DRUG

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

Active Comparator 1; Experimental

Atorvastatin 40mg DRUG

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

Active Comparator 2; Experimental

Placebo for Fimasartan 120mg DRUG

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

Active Comparator 2

Placebo for Atorvastatin 40mg DRUG

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

Active Comparator 1

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension; Dyslipidemias

Interventions

fimasartan; Atorvastatin

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 9, 2017
• Study Start: January 15, 2018
• Primary Completion: April 22, 2019
• Study Completion: April 22, 2019
• Last Updated: November 5, 2019

Record last verified: 2019-10

Locations

KR (1)