A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination of Fimasartan/Rosuvastatin in Comparison to Each Component Administered Alone in Patients With Essential Hypertension and Dyslipidemia

NCT02166814 | Completed Phase 3

• 1 other identifier: BR-FRC-CT-301
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 26

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of combination of Fimasartan/Rosuvastatin in comparison to each component administered alone in patients with essential hypertension and dyslipidemia.

Conditions

Essential Hypertension, Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• Change rate of LDL-C at week 8 of Fimasartan/Rosuvastatin combination administration from the Baseline to compare the one of Fimasartan 120mg single administration

  8 weeks from Baseline Visit

• Change of SiSBP at week 8 of Fimasartan/Rosuvastatin combination administration from the Baseline to compare the one of Rosuvastatin 20mg single administration

  8 weeks from Baseline Visit

Study Arms (3)

Fimasartan and Rosuvastatin

EXPERIMENTAL

Combination of Fimasartan and Rosuvastatin

Drug: Fimasartan and Rosuvastatin

Fimasartan

ACTIVE COMPARATOR

Fimasartan monotherapy

Drug: Fimasartan

Rosuvastatin

ACTIVE COMPARATOR

Rosuvastatin monotherapy

Drug: Rosuvastatin

Interventions

Fimasartan and Rosuvastatin DRUG

Fimasartan and Rosuvastatin

Fimasartan DRUG

Fimasartan

Rosuvastatin DRUG

Rosuvastatin

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who voluntarily signed informed consent for participating in this clinical trial
• Male and female between 20 and 75 years old
• Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (Visit1)
• Patients who meet the following criteria of fasting LDL-C and blood pressure at Baseline visit (Visit3) assessment after undergoing the therapeutic lifestyle change.
• Low risk group: the case that does not have any other risk factor apart from hypertension / LDL-C (mg/dL): ≥160, ≤250, Mean SiSBP(mmHg): ≥140, \<180
• Moderate risk group: the case that has more than or equal to one risk factor apart from hypertension and has the 10-year risk of less than 10% / LDL-C (mg/dL): ≥160, ≤250, Mean SiSBP(mmHg): ≥140, \<180
• Moderate high risk group: the case that has more than or equal to one risk factor apart from hypertension and has the 10-year risk between 10% and 20% / LDL-C (mg/dL): ≥130, ≤250, Mean SiSBP(mmHg): ≥140, \<180
• High risk group: the case of CHD (Coronary heart disease) or CHD risk equivalents
• Risk factors include cigarette smoking, hypertension (BP≥140/90 mmHg or on antihypertensive medication), low HDL cholesterol (\<40mg/dL), family history of premature CHD(CHD in male first-degree relative \<55 years of age; CHD in female first-degree relative \< 65 years of age), and age (men≥45 years; women ≥55 years). in case of HDL-C ≥60mg/dL, reduce 1 from the total number of risk factors.
• Electronic 10 year risk calculators are available at www.nhlbi.nih.gov/guidelines/cholesterol
• CHD includes history of myocardial infarction, unstable angina, coronary artery procedures (angioplasty or bypass surgery), or evidence of clinically significant myocardial ischemia.
• CHD risk equivalents include atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm and carotid artery disease \[transient ischemic attacks or stroke of carotid origin or \>50% obstruction of a carotid artery\]), diabetes and 2+ risk factors with 10 year risk of over 20%
• Subject must be able to understand the trial procedures and be willing to cooperate and complete the trial.

You may not qualify if:

• Severe hypertension patients with mean siSBP ≥ 180mmHg and/or SiDBP ≥110mmHg at the assessment of Screening visit (Visit1) and/or Baseline visit (Visit3). Or patients with postural hypotension with manifestation.
• Patients with the mean SiSBP from 3 times of measurement of over 20mmHg.
• Secondary hypertension patients, but not limited to the following disease (example: renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, etc)
• Secondary dyslipidemia: nephrotic syndrome, dysproteinemia, obstructive hepatopathy or Cushing's syndrome.
• Patients with fasting TG ≥ 400mg/dL at Pre-Baseline visit (Visit2) assessment
• History of myopathy, rhabdomyolysis or/and CK ≥ 2 times upper normal limit.
• Use of lipid modifying drug within 4 weeks prior to Pre-Baseline visit (Visit2) and/or antihypertensive drug within 2 weeks prior to Pre-Baseline visit(Visit2)
• Clinically significant renal function abnormality in the laboratory results at Pre-Baseline visit (i.e. serum creatinine ≥ 1.5 times upper normal limit), liver function abnormality (ALT, AST ≥ 2 times upper normal limit), severe fatty liver disease that requires medication.
• Clinically significant hypokalemia(less than 3.5 mmol/L) or hyperkalemia (exceeded 5.5 mmol/L) measured at Pre-Baseline visit (Visit2)
• Subjects with following surgical and internal disease that may affect absorption, distribution, metabolism or excretion of drugs and have conditions which include the following (but are not limited to): history of major gastrointestinal surgeries including gastrectomy, gastro-enterostomy or bowel resection, gastrointestinal bypass graft and stabling; current active gastritis, ulcer, gastrointestinal and rectal bleeding, presence of active inflammatory bowel syndrome or biliary obstruction with the past 12 months.
• Subjects with depletion of body fluid or sodium ion not able to correct
• Subjects with sever insulin-dependent Diabetes Mellitus(DM) or Chronic DM (HbA1c \> 9% at Pre-Baseline visit, dosage of an oral hypoglycemic agent was modified within 12 weeks prior to screening visit , or currently use of active insulin treatment) or with hypothyroidism not able to correct.( TSH ≥ 1.5 times upper normal limit)
• Subjects with severe heart disease (Heart failure New York Heart Association(NYHA) class 3 and 4), or history of any of the followings within the past 6 months; ischemic heart disease (e.g. angina pectoris, myocardial infarction), peripheral vascular disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft.
• Subjects with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or any other clinical significant arrhythmia conditions at discretion of investigator
• Subjects with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve stenosis, or mitral valve stenosis.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (26)

Seoul university Bundang hospital

Bundang, South Korea

Location

Dong-A university hospital

Busan, South Korea

Location

Inje Heaundai Paik hospital

Busan, South Korea

Location

Inje university Busan Paik hospital

Busan, South Korea

Location

The Catholic university of Korea Daegu hospital

Daegu, South Korea

Location

DongGuk university Gyeongju hospital

Gyeongju, South Korea

Location

DongGuk university Ilsan hospital

Ilsan, South Korea

Location

Inje university Ilsan Paik hospital

Ilsan, South Korea

Location

Gachon university Gil medical center

Incheon, South Korea

Location

Inha university hospital

Incheon, South Korea

Location

Jeju national university hospital

Jeju City, South Korea

Location

JeonNam university hospital

JeonNam, South Korea

Location

ChungNam university hospital

Jungnam, South Korea

Location

DanGuk university hospital

Jungnam, South Korea

Location

Kyungbook National university hospital

Kyungbook, South Korea

Location

Gangnam Severance hospital

Seoul, South Korea

Location

Jeil hospital

Seoul, South Korea

Location

Korea university Anam hospital

Seoul, South Korea

Location

Korea university Guro hospital

Seoul, South Korea

Location

Kyunghee university hospital

Seoul, South Korea

Location

Samsung Seoul hospital

Seoul, South Korea

Location

Seoul national university hospital

Seoul, South Korea

Location

Severance hospital

Seoul, South Korea

Location

The Catholic university St. Mary hospital

Seoul, South Korea

Location

Aju university hospital

Suwon, South Korea

Location

YoungNam university hospital

YoungNam, South Korea

Location

Related Publications (1)

• Rhee MY, Ahn T, Chang K, Chae SC, Yang TH, Shim WJ, Kang TS, Ryu JK, Nah DY, Park TH, Chae IH, Park SW, Lee HY, Tahk SJ, Yoon YW, Shim CY, Shin DG, Seo HS, Lee SY, Kim DI, Kwan J, Joo SJ, Jeong MH, Jeong JO, Sung KC, Kim SY, Kim SH, Chun KJ, Oh DJ. The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia. BMC Pharmacol Toxicol. 2017 Jan 5;18(1):2. doi: 10.1186/s40360-016-0112-7.

  PMID: 28057081 DERIVED

MeSH Terms

Conditions

Essential Hypertension; Dyslipidemias

Interventions

fimasartan; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dongjoo Oh

  Korea University Guro Hospital

  STUDY CHAIR

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: June 16, 2014
• First Posted: June 18, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 13, 2017

Record last verified: 2014-06

Locations

KR (26)