A Randomized, Double-Blind, Placebo-Controlled, 3x3 Factorial Design, Phase II Study to Evaluate the Antihypertensive Efficacy and Safety of Combination of Fimasartan and Amlodipine in Patients With Essential Hypertension

Boryung

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: Fimasartan , Amlodipine, Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01518998

BR-FAC-CT-201

Details and patient eligibility

About

The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan

Enrollment: 420 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects who agreed to participate in this study and submitted the written informed consent
2. Subjects aged 20 to 75 years
3. Essential hypertension subjects who are measured more 90mmHg, less than 114mmHg of sitting diastolic blood pressure (SiDBP) at baseline(day 0).
4. Subjects who considered to understand this study , be cooperative, and able to be followed-up whole of the study period.

Exclusion criteria

1. Severe hypertension patients; more 115mmHg of SiDBP and/or more 185 mmHg of Sitting systolic blood pressure (SiSBP)
2. Patients with secondary hypertension
3. Patients with significant investigations - abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication
4. Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
5. Patients with sodium ion or body fluid is depleted and not able to correct
6. Patients with hypotension who has sign and symptom
7. Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion
8. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, regimen change of oral hypoglycemic agent, using insulin)
9. Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
10. Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
11. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
12. Patients with severe cerebrovascular disease
13. Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous.
14. Patients with known severe or malignancy retinopathy
15. Patients with hepatitis B or C or HIV positive reaction
16. Patients who have a story or evidence of alcohol or drug abuse within 2years
17. Patients who are measured the mean difference of mean blood pressure of both arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit
18. Patients with history of allergic reaction to any angiotensin II antagonist
19. Patients with any chronic inflammation disease needed to chronic inflammation therapy
20. Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin
21. Childbearing and breast-feeding women
22. Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
23. Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial
24. Subject who are judged unsuitable to participate in this study by investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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420 participants in 9 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Take one double-blind capsule filled with a placebo tablet in the every morning

Treatment:

Drug: Fimasartan , Amlodipine, Placebo

Fimasartan 60mg

Active Comparator group

Description:

Take one double-blind capsule filled with of Fimasartan 60mg in the every morning

Treatment:

Drug: Fimasartan , Amlodipine, Placebo

Fimasartan 30mg

Active Comparator group

Description:

Take one double-blind capsule filled with Fimasartan 30mg in the every morning

Treatment:

Drug: Fimasartan , Amlodipine, Placebo

Amlodipine 5mg

Active Comparator group

Description:

Take one double-blind capsule filled with Amlodipine 5mg in the every morning

Treatment:

Drug: Fimasartan , Amlodipine, Placebo

Amlodipine 10mg

Active Comparator group

Description:

Take one double-blind capsule filled with Amlodipine 10mg in the every morning

Treatment:

Drug: Fimasartan , Amlodipine, Placebo

Fimasartan 60mg/ Amlodipine 5mg

Experimental group

Description:

Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 5mg in the every morning

Treatment:

Drug: Fimasartan , Amlodipine, Placebo

Fimasartan 60mg/Amlodipine 10mg

Experimental group

Description:

Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 10mg in the every morning

Treatment:

Drug: Fimasartan , Amlodipine, Placebo

Fimasartan 30mg/Amlodipine 5mg

Experimental group

Description:

Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 5mg in the every morning

Treatment:

Drug: Fimasartan , Amlodipine, Placebo

Fimasartan 30mg/Amlodipine 10mg

Experimental group

Description:

Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 10mg in the every morning

Treatment:

Drug: Fimasartan , Amlodipine, Placebo