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

• Sponsor: Boryung Pharmaceutical Co., Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02166814
• Collaborator: (none)
• Enrollment: 140
• Locations: 26
• Arms: 3
• Duration (Months): 13
• Patients Per Site: 5.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension, Dyslipidemia	Drug: Fimasartan and Rosuvastatin; Drug: Fimasartan; Drug: Rosuvastatin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fimasartan and Rosuvastatin Combination of Fimasartan and Rosuvastatin	Drug: Fimasartan and Rosuvastatin
Active Comparator: Fimasartan Fimasartan monotherapy	Drug: Fimasartan
Active Comparator: Rosuvastatin Rosuvastatin monotherapy	Drug: Rosuvastatin

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients who voluntarily signed informed consent for participating in this clinical trial

2. Male and female between 20 and 75 years old

3. Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (Visit1)

4. 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%

1. Subject must be able to understand the trial procedures and be willing to cooperate and complete the trial.

Exclusion Criteria:

1. 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.

2. Patients with the mean SiSBP from 3 times of measurement of over 20mmHg.

3. 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)

4. Secondary dyslipidemia: nephrotic syndrome, dysproteinemia, obstructive hepatopathy or Cushing's syndrome.

5. Patients with fasting TG ≥ 400mg/dL at Pre-Baseline visit (Visit2) assessment

6. History of myopathy, rhabdomyolysis or/and CK ≥ 2 times upper normal limit.

7. 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)

8. 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.

9. Clinically significant hypokalemia(less than 3.5 mmol/L) or hyperkalemia (exceeded 5.5 mmol/L) measured at Pre-Baseline visit (Visit2)

10. 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.

11. Subjects with depletion of body fluid or sodium ion not able to correct

12. 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)

13. 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.

14. Subjects with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or any other clinical significant arrhythmia conditions at discretion of investigator

15. Subjects with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve stenosis, or mitral valve stenosis.

16. Subjects with severe cerebrovascular disorder (e.g. stroke, cerebral infarction or cerebral hemorrhage within the past 6 months)

17. Subjects with chronic inflammatory disease requiring an chronic anti-inflammatory therapy, past or current medical history with wasting disease, autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus) or connective tissue disease.

18. Subjects with known moderate or malignant retinosis (e.g. retinal hemorrhage, visual disturbance or retinal microaneurysm in the past 6 months)

19. Subjects with hepatitis B (including positive test for HBsAg), hepatitis C-positive

20. Subjects with history or evidence of abusing drugs or alcohol within the past 2 years.

21. Medical history with hypersensitivity to angiotensin II antagonist based drugs or HMG-CoA reductase inhibitor based drugs or any ingredient contained in these 2 drugs.

22. Medical history with clinically significant hypersensitivity to any components or other drugs on the investigational product or additives (yellow 5)

23. Subjects with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

24. Pregnant women and lactating female.

25. Subjects planning pregnancy or childbearing potential who are not using effective contraceptive methods (surgical sterilized, intrauterine (contraceptive) device/condom or the combination of diaphragm and spermicidal agents)

26. Subjects who are participating in another trial or took other investigational product within 12 weeks prior to Screening visit

27. Medical history of all kinds of malignant tumor including leukemia and lymphoma in the past 5 years

28. A subject with other reasons not specified above that, ineligible to participate in this clinical trial at discretion of study investigators.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul university Bundang hospital	Bundang		Korea, Republic of
2	Dong-A university hospital	Busan		Korea, Republic of
3	Inje Heaundai Paik hospital	Busan		Korea, Republic of
4	Inje university Busan Paik hospital	Busan		Korea, Republic of
5	ChungNam university hospital	ChungNam		Korea, Republic of
6	DanGuk university hospital	Chungnam		Korea, Republic of
7	The Catholic university of Korea Daegu hospital	Daegu		Korea, Republic of
8	DongGuk university Gyeongju hospital	Gyeongju		Korea, Republic of
9	DongGuk university Ilsan hospital	Ilsan		Korea, Republic of
10	Inje university Ilsan Paik hospital	Ilsan		Korea, Republic of
11	Gachon university Gil medical center	Incheon		Korea, Republic of
12	Inha university hospital	Incheon		Korea, Republic of
13	Jeju national university hospital	Jeju		Korea, Republic of
14	JeonNam university hospital	JeonNam		Korea, Republic of
15	Kyungbook National university hospital	Kyungbook		Korea, Republic of
16	Gangnam Severance hospital	Seoul		Korea, Republic of
17	Jeil hospital	Seoul		Korea, Republic of
18	Korea university Anam hospital	Seoul		Korea, Republic of
19	Korea university Guro hospital	Seoul		Korea, Republic of
20	Kyunghee university hospital	Seoul		Korea, Republic of
21	Samsung Seoul hospital	Seoul		Korea, Republic of
22	Seoul national university hospital	Seoul		Korea, Republic of
23	Severance hospital	Seoul		Korea, Republic of
24	The Catholic university St. Mary hospital	Seoul		Korea, Republic of
25	Aju university hospital	Suwon		Korea, Republic of
26	YoungNam university hospital	YoungNam		Korea, Republic of

Sponsors and Collaborators

• Boryung Pharmaceutical Co., Ltd

Investigators

• Study Chair: Dongjoo Oh, Korea University Guro Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boryung Pharmaceutical Co., Ltd
• ClinicalTrials.gov Identifier: NCT02166814
• Other Study ID Numbers: BR-FRC-CT-301
• First Posted: Jun 18, 2014
• Last Update Posted: Feb 13, 2017
• Last Verified: Jun 1, 2014

• Additional relevant MeSH terms: Hypertension; Essential Hypertension; Dyslipidemias; Rosuvastatin Calcium

Study Results

No Results Posted as of Feb 13, 2017