Antihypertensive Efficacy and Tolerability and Determine the Adequate Antihypertensive Dosage of Fimasartan in Mild to Moderate Essential Hypertension Patients

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Drug: Fimasartan

• Registration Number: NCT00923611
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

The purpose of this study is to evaluate the antihypertensive efficacy and tolerability of 8 week treatment with Fimasartan (BR-A-657-K) 20, 60, 120, 240 mg and placebo in patients with mild to moderate essential hypertension and to determine the adequate antihypertensive dosage for later clinical study.

Detailed Description

Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan (BR-A-657-K) 20mg \~ 480mg single dosing with healthy subjects, demonstrated that the Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose.

A randomized, double-blind, placebo-controlled, parallel grouped, clinical study will be conducted to evaluate the antihypertensive efficacy and tolerability and to determine adequate antihypertensive dosage of Fimasartan(BR-A-657-K) in patients with mild to moderate essential hypertension.

Approximately 182 patients will be enrolled over 12 months in 8 centers nationwide.

After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 5 groups. Subjects will take test/control drug for 8 weeks of treatment period. If subjects take any antihypertensive medications before screening, the subjects will have 1 week of wash-out period.

Group I : Placebo, Group II : Fimasartan 20 mg, Group III: Fimasartan 60 mg, Group IV : Fimasartan 120 mg, Group V : Fimasartan 240 mg,

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2009-06
• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-17
• Last Update Submitted: 2009-06-17
• Study First Posted: 2009-06-18
• Last Update Posted: 2009-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• Mild to moderate essential hypertension : sitting diastolic blood pressure measured at Screening and Baseline(Day1) are 95~114 mmHg inclusive and the difference between sitting diastolic blood pressures measured at Day -14 and Baseline(Day1) is under 7mmHg.
• Subjects who agree to participate in this sudy and give written informed consent
• Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study

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Exclusion Criteria

• The sitting DBP is less than 94mmHg or more than 115mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg
• Patients with secondary hypertension
• Patients with severe renal(Creatinine more 1.5 times than upper limit of normal), gastrointestinal, hematological or hepatic(AST, ALT more 2 twice more than upper limit of normal)disease etc. which might affect absorption, disposition, metabolism or excretion of the drug
• Patients with postural hypotension
• Patients with sever insulin dependent diabetes mellitus or uncontrolled diabetes mellitus(HbA1c>9%, regimen change of oral hypoglycemic agents within 3 months, treated insulin before screening)
• Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months
• Patients with consumptive disease, autoimmune disease, connective tissue disease
• Patients with a history of type B or C hepatitis
• Patients with HIV or hepatitis
• Patients with clinically significant laboratory abnormality
• Patients receiving any drugs known to affect blood pressure or medical treatments that can influence the blood pressure
• Patients with allergy or contraindication to any angiotensin II receptor antagonists
• Female of childbearing potential who does not undergo hysterectomy or is not post-menopausal
• Patients judged to have a history of alcohol or drug abuse by the investigator
• Patients with average weight > +35% or <-15% in Modified Metropolitan Life Insurance table
• Patients participated other clinical trial 3 months before Screening
• Patients judged to be inappropriate for this study by the investigator with other reasons

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Fimasartan	3 tablets of placebo will be taken 30minutes after breakfast for 8 weeks
Fimasartan 20mg	Fimasartan	2 tablets of placebo and 1 tablets of fimasartan 20mg will be taken 30minutes after breakfast for 8 weeks
Fimasartan 240mg	Fimasartan	3 tablets of fimasartan 80mg will be taken 30minutes after breakfast for 8 weeks
Fimasartan 60mg	Fimasartan	3 tablets of fimasartan 20mg will be taken 30minutes after breakfast for 8 weeks
Fimasartan 120mg	Fimasartan	3 tablets of fimasartan 40mg will be taken 30minutes after breakfast

Primary Outcome Measures

Name	Time	Method
change from baseline to end of 8 week treatment in sitting diastolic blood pressure	8 week from baseline

Secondary Outcome Measures

Name	Time	Method
change from baseline to end of 2,4 week treatment in sitting diastolic blood pressure	2, 4 week from baseline
change from baseline to end of 2,4,8 week treatment in sitting systolic blood pressure	2,4,8 week from baseline
responders after end of 8 week treatment(portion of DBP<90mmHg or the difference from baseline and end of 8 week treatment>10mmHg	8 week from baseline

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of