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

NCT01135212 | Completed Phase 3 DMC

• 1 other identifier: A657-BR-CT-302
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Hypertension; ARB; Fimasartan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sitting DBP

  at 12weeks from Baseline visit

• SittingDBP

  at 4, 8 weeks from baseline visit

• Sitting Systolic Blood Pressure

  at 4,8,12 weeks from baseline visit

• Responder ratio

  at 12weeks from baseline visit

Study Arms (3)

Fimasartan 60mg

ACTIVE COMPARATOR

Take one tablet of Fimasartan 60mg once a day in the morning

Drug: Fimasartan 60mg

Fimasartan 120mg

ACTIVE COMPARATOR

Take one tablet of Fimasartan 120mg once a day in the morning

Drug: Fimasartan 120mg

Candesartan 8mg

ACTIVE COMPARATOR

Take one tablet of Candesartan 8mg once a day in the morning

Drug: Candesartan cilexetil

Interventions

Fimasartan 60mg DRUG

Fimasartan 60mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.

Fimasartan 60mg

Fimasartan 120mg DRUG

Fimasartan 120mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.

Fimasartan 120mg

Candesartan cilexetil DRUG

Candesartan 8mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.

Also known as: Atacand 8mg

Candesartan 8mg

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who agreed to participate in this study and submitted the written informed consent
• Subjects aged 19 to 75 years
• Mild to moderate essential hypertension subjects who are measured more 90mmHg, less than 110mmHg of sitting diastolic blood pressure (SiDBP) at baseline(day 0).
• Subjects who considered to understand this study , be cooperative, and able to be followed-up whole of the study period.

You may not qualify if:

• Severe hypertension patients; more 110mmHg of SiDBP and/or more 180 mmHg of Sitting systolic blood pressure (SiSBP)
• Patients with secondary hypertension
• 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
• Patients with hypotension who has sign and symptom
• Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion
• Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c \> 9%, regimen change of oral hypoglycemic agent, using insulin)
• Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
• Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
• Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
• Patients with severe cerebrovascular disease
• Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous.
• Patients with known severe or malignancy retinopathy
• Patients with hepatitis B or C or HIV positive reaction
• Patients who have a story or evidence of alcohol or drug abuse within 2years
• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead
• Kyungpook National University Hospital: collaborator
• Gyeongsang National University Hospital: collaborator
• Keimyung University: collaborator
• Kosin University Gospel Hospital: collaborator
• Daegu Catholic University Medical Center: collaborator
• Dong-A medical center: collaborator
• Pusan National University Yangsan Hospital: collaborator
• Yeungnam University Hospital: collaborator
• Ulsan University Hospital: collaborator
• Inje University: collaborator
• Pusan National University Hospital: collaborator

Study Sites (1)

KyungPook National University Hospital

Daegu, Daegu, 110-750, South Korea

Location

Related Publications (2)

• 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.

  PMID: 27161546 DERIVED

• Fimasartan. Am J Cardiovasc Drugs. 2011 Aug 1;11(4):249-52. doi: 10.2165/11533640-000000000-00000.

  PMID: 21740078 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

fimasartan; candesartan cilexetil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• ShungChull Chae, Doctor´s degree

  KuyngPook National Hospital

  PRINCIPAL INVESTIGATOR

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: May 31, 2010
• First Posted: June 2, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 24, 2012

Record last verified: 2012-08

Locations

KR (1)