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

NCT ID: NCT03156842

Last Updated: 2019-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-29
• Study Completion Date: 2018-12-07

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.

Conditions

Essential Hypertension; Dyslipidemia

Study Design

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

Study Groups

Fimasartan/Amlodipine, Rosuvastatin

Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin

Group Type: EXPERIMENTAL

Fimasartan/Amlodipine, Rosuvastatin

Intervention Type: DRUG

"A fixed dose combination tablet of Fimasartan and Amlodipine" and "Rosuvastatin" will be administrated once daily on treatment period.

Fimasartan/Amlodipine

a fixed dose combination of Fimasartan/Amlodipine

Group Type: ACTIVE_COMPARATOR

Fimasartan/Amlodipine

Intervention Type: DRUG

"A fixed dose combination tablet of Fimasartan and Amlodipine" will be administrated once daily on treatment period.

Fimasartan, Rosuvastatin

Co-administration of Fimasartan and Rosuvastatin

Group Type: ACTIVE_COMPARATOR

Fimasartan, Rosuvastatin

Intervention Type: DRUG

"Fimasartan" and "Rosuvastatin" will be administrated once daily on treatment period.

Interventions

Fimasartan/Amlodipine, Rosuvastatin

"A fixed dose combination tablet of Fimasartan and Amlodipine" and "Rosuvastatin" will be administrated once daily on treatment period.

Intervention Type: DRUG

Fimasartan/Amlodipine

"A fixed dose combination tablet of Fimasartan and Amlodipine" will be administrated once daily on treatment period.

Intervention Type: DRUG

Fimasartan, Rosuvastatin

"Fimasartan" and "Rosuvastatin" will be administrated once daily on 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 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.)

• Minimum Eligible Age: 20 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

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

Jeon ES, Lim SW, Kim SY, Yang HM, Kim MH, Rhee MY, Han SH, Shin J, Kim KI, Jeong JO, Sung KC, Hong GR, Kim HS, Kwon K, Kang TS, Lee HY, Han SE. A randomized, double-blind, multicenter, phase III study on the efficacy and safety of a combination treatment involving fimasartan, amlodipine, rosuvastatin in patients with essential hypertension and dyslipidemia who fail to respond adequately to fimasartan monotherapy. Clin Hypertens. 2022 Dec 1;28(1):40. doi: 10.1186/s40885-022-00223-4.

Reference Type: DERIVED

PMID: 36451242 (View on PubMed)

Other Identifiers

BR-FARC-CT-301

Identifier Type: -

Identifier Source: org_study_id