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

NCT03156842 | Completed Phase 3

• 1 other identifier: BR-FARC-CT-301
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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

Keywords

Hypertension; Dyslipidemia; Fimasartan; Rosuvastatin

Outcome Measures

Primary Outcomes (2)

• LDL-C

  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

  8weeks from Baseline Visit

• Sitting systolic blood pressure(SiSBP)

  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

  8weeks from Baseline Visit

Secondary Outcomes (2)

• Sitting systolic blood pressure(SiSBP)

  8weeks from Baseline Visit

• LDL-C

  8weeks from Baseline Visit

Study Arms (3)

Fimasartan/Amlodipine, Rosuvastatin

EXPERIMENTAL

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

Drug: Fimasartan/Amlodipine, Rosuvastatin

Fimasartan/Amlodipine

ACTIVE COMPARATOR

a fixed dose combination of Fimasartan/Amlodipine

Drug: Fimasartan/Amlodipine

Fimasartan, Rosuvastatin

ACTIVE COMPARATOR

Co-administration of Fimasartan and Rosuvastatin

Drug: Fimasartan, Rosuvastatin

Interventions

Fimasartan/Amlodipine, Rosuvastatin DRUG

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

Fimasartan/Amlodipine, Rosuvastatin

Fimasartan/Amlodipine DRUG

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

Fimasartan/Amlodipine

Fimasartan, Rosuvastatin DRUG

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

Fimasartan, Rosuvastatin

Eligibility Criteria

• Age: 20 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 Sitting systolic blood pressure(SiSBP) \< 180 mmHg) at the baseline visit (V3) after the fimasartan 60 mg monotherapy
• Subjects who meet the following criteria of fasting serum lipid levels confirmed at the baseline visit (V3) after undergoing the therapeutic lifestyle change (TLC)
• Treatment compliance of fimasartan 60 mg ≥70% at the baseline visit (V3)
• 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 baseline visit (V2, or orthostatic hypotension accompanied by symptoms
• 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)
• 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 of normal 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 disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc. within 6 months prior to the screening visit (V1)
• 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
• 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.)

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 36451242 DERIVED

MeSH Terms

Conditions

Essential Hypertension; Dyslipidemias; Hypertension

Interventions

fimasartan; Amlodipine; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

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: May 14, 2017
• First Posted: May 17, 2017
• Study Start: May 29, 2017
• Primary Completion: December 7, 2018
• Study Completion: December 7, 2018
• Last Updated: June 10, 2019

Record last verified: 2019-06

Locations

KR (1)