The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension

A Randomized, Double-blind, Candesartan-controlled, Parallel Group Comparison Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension (Phase IIIb)

The purpose of this clinical study is to evaluate and compare the efficacy and safety of Fimasartan (60mg / 120mg) with Candesartan(8mg) in patients with mild to moderate hypertension.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Fimasartan 60mg; Drug: Fimasartan 120mg; Drug: Candesartan cilexetil

Detailed Description

A randomized, double-blind, Candesartan controlled, parallel group comparison clinical study to evaluate the antihypertensive efficacy and safety of Fimasartan in patients with mild to moderate hypertension Approximately 288 patients will be enrolled in 10 centers in South Korea. This study has planned 5 visits during 14 weeks (placebo run-in period 2 weeks, treatment period 12 weeks). All of the subjects who agreed to participate in this study and gave the written informed consent voluntary are assessed the exclusion and inclusion criteria and receive the investigational product(placebo) at screening visit.

During more than 14 days of placebo run-in period, subjects have to stop the previous anti-hypertension drug. After 2 weeks, subjects are assessed the final eligibility and randomized into one of 3 groups(Fimasartan 60mg, Fimasartan 120mg, Candesartan 8mg) at baseline visit. Subjects take physical and laboratory tests and receive the investigational products per 4weeks during treatment period (12weeks).

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 110-750
    • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 73 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 19 to 75 years
3. Mild to moderate essential hypertension subjects who are measured more 90mmHg, less than 110mmHg 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 110mmHg of SiDBP and/or more 180 mmHg of Sitting systolic blood pressure (SiSBP)
2. Patients with secondary hypertension
3. Patients with significant investigations - abnormal renal function (Creatinine more than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication
4. Patients with hypotension who has sign and symptom
5. Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion
6. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, regimen change of oral hypoglycemic agent, using insulin)
7. Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
8. Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
9. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
10. Patients with severe cerebrovascular disease
11. Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous.
12. Patients with known severe or malignancy retinopathy
13. Patients with hepatitis B or C or HIV positive reaction
14. Patients who have a story or evidence of alcohol or drug abuse within 2years
15. 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
16. Patients with history of allergic reaction to any angiotensin II antagonist
17. Patients with any chronic inflammation disease needed to chronic inflammation therapy
18. Childbearing and breast-feeding women
19. Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
20. Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial
21. 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: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fimasartan 60mg; Take one tablet of Fimasartan 60mg once a day in the morning	Drug: Fimasartan 60mg; Fimasartan 60mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
Active Comparator: Fimasartan 120mg; Take one tablet of Fimasartan 120mg once a day in the morning	Drug: Fimasartan 120mg; Fimasartan 120mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
Active Comparator: Candesartan 8mg; Take one tablet of Candesartan 8mg once a day in the morning	Drug: Candesartan cilexetil; Candesartan 8mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.; Other Names: Atacand 8mg

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 12 weeks from baseline visit Fimasartan 60mg with Candesartna 8mg	12weeks from baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sitting DBP	To compare the difference of Sitting Diastolic Blood Pressure at 12 weeks from baseline visit Fimasartan 120mg with Candesartna 8mg	at 12weeks from Baseline visit
SittingDBP	To compare the difference of Sitting Diastolic Blood Pressure at 4, 8 weeks from baseline visit Fimasartan 60/120mg with Candesartna 8mg	at 4, 8 weeks from baseline visit
Sitting Systolic Blood Pressure	To compare the difference of Sitting Systolic Blood Pressure at 4,8,12 weeks from baseline visit Fimasartan 60mg/120mg with Candesartna 8mg	at 4,8,12 weeks from baseline visit
Responder ratio	To compare the ratio or responder(SiDBP<90mmHg or difference of SiDBP>10mmHg from baseline) at 12 weeks Fimasartan 60mg/120mg with Candesartna 8mg	at 12weeks from baseline visit

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborators: Pusan National University Hospital; Ulsan University Hospital; Daegu Catholic University Medical Center; Kyungpook National University Hospital; Inje University; Gyeongsang National University Hospital; Yeungnam University Hospital; Pusan National University Yangsan Hospital; Kosin University Gospel Hospital; Keimyung University; Dong-A medical center
• Investigators: Principal Investigator: ShungChull Chae, Doctor´s degree, KuyngPook National Hospital

Publications and helpful links

General Publications

• Fimasartan. Am J Cardiovasc Drugs. 2011 Aug 1;11(4):249-52. doi: 10.2165/11533640-000000000-00000.
• Lee JH, Yang DH, Hwang JY, Hur SH, Cha TJ, Kim KS, Kim MH, Chun KJ, Cha GS, Hong GR, Lee SG, Kim DS, Kim DI, Chae SC. A Randomized, Double-blind, Candesartan-controlled, Parallel Group Comparison Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Patients with Mild to Moderate Essential Hypertension. Clin Ther. 2016 Jun;38(6):1485-1497. doi: 10.1016/j.clinthera.2016.04.005. Epub 2016 May 6.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: May 31, 2010
• First Submitted That Met QC Criteria: June 1, 2010
• First Posted (Estimate): June 2, 2010

Study Record Updates

• Last Update Posted (Estimate): August 24, 2012
• Last Update Submitted That Met QC Criteria: August 22, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Hypertension; Fimasartan; ARB
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Candesartan; Candesartan cilexetil
• Other Study ID Numbers: A657-BR-CT-302