Combination of Fimasartan/Amlodipine/Rosuvastatin in Patients With Essential Hypertension and Dyslipidemia

Phase 3

Completed

• Conditions: Dyslipidemia; Essential Hypertension
• Interventions: Drug: Fimasartan, Rosuvastatin; Drug: Fimasartan/Amlodipine, Rosuvastatin; Drug: Fimasartan/Amlodipine

• Registration Number: NCT03156842
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

The objective of this clinical study is to evaluate the efficacy and safety by comparing the fimasartan/amlodipine/rosuvastatin treatment group to the fimasartan/amlodipine treatment group and the fimasartan/rosuvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia who fail to respond to the fimasartan monotherapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-14
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-17
• Study Start: 2017-05-29
• Primary Completion: 2018-12-07
• Study Completion: 2018-12-07
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-07
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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 Sitting systolic blood pressure(SiSBP) < 180 mmHg) at the baseline visit (V3) after the fimasartan 60 mg monotherapy
5. Subjects who meet the following criteria of fasting serum lipid levels confirmed at the baseline visit (V3) after undergoing the therapeutic lifestyle change (TLC)
6. Treatment compliance of fimasartan 60 mg ≥70% at the baseline visit (V3)
7. 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 baseline visit (V2, or orthostatic hypotension accompanied by symptoms
2. Differences between arms greater than 20 mmHg for Sitting systolic blood pressure(SiSBP) and 10 mmHg for Sitting diastolic blood pressure(SiDBP) are present on 3 consecutive readings 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 of normal 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 disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc. within 6 months prior to the screening visit (V1)
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
10. Planning pregnancy during the study period or have childbearing potential but are not using acceptable contraceptive methods (Contraceptive methods: Refer to Section 10.1 in this document.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fimasartan, Rosuvastatin	Fimasartan, Rosuvastatin	Co-administration of Fimasartan and Rosuvastatin
Fimasartan/Amlodipine, Rosuvastatin	Fimasartan/Amlodipine, Rosuvastatin	Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin
Fimasartan/Amlodipine	Fimasartan/Amlodipine	a fixed dose combination of Fimasartan/Amlodipine

Primary Outcome Measures

Name	Time	Method
Sitting systolic blood pressure(SiSBP)	8weeks from Baseline Visit	The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group at Week 8 compared to the fimasartan 60 mg and rosuvastatin 20 mg concomitant treatment group
LDL-C	8weeks from Baseline Visit	The percent change in LDL-C from baseline in the test group at Week 8 compared to the fimasartan 60 mg/amlodipine 10 mg combination treatment group

Secondary Outcome Measures

Name	Time	Method
Sitting systolic blood pressure(SiSBP)	8weeks from Baseline Visit	The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group at Week 8 compared to the fimasartan 60 mg/amlodipine 10 mg combination treatment group
LDL-C	8weeks from Baseline Visit	The percent change in LDL-C from baseline in the test group at Week 8 compared to the fimasartan 60 mg and rosuvastatin 20 mg concomitant treatment group

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of