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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Fimasartan , Amlodipine, Placebo

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Take one double-blind capsule filled with a placebo tablet in the every morning	Drug: Fimasartan , Amlodipine, Placebo; Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination; Other Names: Norvasc; Kanarb
Active Comparator: Fimasartan 60mg; Take one double-blind capsule filled with of Fimasartan 60mg in the every morning	Drug: Fimasartan , Amlodipine, Placebo; Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination; Other Names: Norvasc; Kanarb
Active Comparator: Fimasartan 30mg; Take one double-blind capsule filled with Fimasartan 30mg in the every morning	Drug: Fimasartan , Amlodipine, Placebo; Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination; Other Names: Norvasc; Kanarb
Active Comparator: Amlodipine 5mg; Take one double-blind capsule filled with Amlodipine 5mg in the every morning	Drug: Fimasartan , Amlodipine, Placebo; Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination; Other Names: Norvasc; Kanarb
Active Comparator: Amlodipine 10mg; Take one double-blind capsule filled with Amlodipine 10mg in the every morning	Drug: Fimasartan , Amlodipine, Placebo; Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination; Other Names: Norvasc; Kanarb
Experimental: Fimasartan 60mg/ Amlodipine 5mg; Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 5mg in the every morning	Drug: Fimasartan , Amlodipine, Placebo; Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination; Other Names: Norvasc; Kanarb
Experimental: Fimasartan 60mg/Amlodipine 10mg; Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 10mg in the every morning	Drug: Fimasartan , Amlodipine, Placebo; Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination; Other Names: Norvasc; Kanarb
Experimental: Fimasartan 30mg/Amlodipine 5mg; Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 5mg in the every morning	Drug: Fimasartan , Amlodipine, Placebo; Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination; Other Names: Norvasc; Kanarb
Experimental: Fimasartan 30mg/Amlodipine 10mg; Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 10mg in the every morning	Drug: Fimasartan , Amlodipine, Placebo; Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination; Other Names: Norvasc; Kanarb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sitting Diastolic Blood Pressure	To compare the difference of Sitting Diastolic Blood Pressure at 8 weeks from baseline visit	8weeks from baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sitting Systolic Blood Pressure	To compare the difference of Sitting Systolic Blood Pressure at 4,8 weeks from baseline visit	at 4 and 8 weeks from Baseline visit
Sitting Diastolic Blood Pressure	To compare the difference of Sitting Diastolic Blood Pressure at 4 weeks from baseline visit	4weeks from baseline visit
Responder ratio	To compare the ratio or responder(SiDBP<90mmHg or difference of SiDBP>10mmHg from baseline) at 8 weeks	at 8weeks from baseline visit

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborators: Samsung Medical Center; Asan Medical Center; Chonnam National University Hospital; Seoul National University Hospital; Seoul National University Bundang Hospital; Korea University Guro Hospital; Cheil General Hospital and Women's Healthcare Center; Gachon University Gil Medical Center; Daegu Catholic University Medical Center; Kyungpook National University Hospital; Inje University; Yeungnam University Hospital; The Catholic University of Korea; Kangbuk Samsung Hospital; Soon Chun Hyang University; Hanyang University Seoul Hospital; Jeju National University Hospital; Wonju Severance Christian Hospital; Wonkwang University Hospital; Hallym University Kangnam Sacred Heart Hospital; DongGuk University; Inha University Hospital; Chungnam National University; Catholic University of Korea Saint Paul's Hospital; Busan National University Yangsan Hospital
• Investigators: Study Director: Young Kwan Jeon, Medical Director, Boryung Pharmaceutical Co., Ltd

Publications and helpful links

General Publications

• Lee HY, Kim YJ, Ahn T, Youn HJ, Chull Chae S, Seog Seo H, Kim KS, Rhee MY, Choi DJ, Kim JJ, Chun KJ, Yoo BS, Park JS, Oh SK, Kim DS, Kwan J, Ahn Y, Bae Park J, Jeong JO, Hyon MS, Cho EJ, Han KR, Kim DI, Joo SJ, Shin JH, Sung KC, Jeon ES. A Randomized, Multicenter, Double-blind, Placebo-controlled, 3 x 3 Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of the Combination of Fimasartan/Amlodipine in Patients With Essential Hypertension. Clin Ther. 2015 Nov 1;37(11):2581-2596.e3. doi: 10.1016/j.clinthera.2015.02.019. Epub 2015 Apr 4.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: January 24, 2012
• First Submitted That Met QC Criteria: January 24, 2012
• First Posted (Estimate): January 26, 2012

Study Record Updates

• Last Update Posted (Estimate): July 1, 2016
• Last Update Submitted That Met QC Criteria: June 29, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Amlodipine; Fimasartan; antihypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Amlodipine
• Other Study ID Numbers: BR-FAC-CT-201