Trial | NCT01135212  Report issue

Title

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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fimasartan candesartan ...

  • Study Participants

    290
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.
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 Started
Apr 30
2010
Primary Completion
Apr 30
2011
Study Completion
May 31
2011
Last Update
Aug 24
2012
Estimate

Drug Fimasartan 60mg

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

Drug Fimasartan 120mg

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

Drug Candesartan cilexetil

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

  • Other names: Atacand 8mg

Fimasartan 60mg Active Comparator

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

Fimasartan 120mg Active Comparator

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

Candesartan 8mg Active Comparator

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

Criteria 

Inclusion Criteria:

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.

Exclusion Criteria:

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
Patients with history of allergic reaction to any angiotensin II antagonist
Patients with any chronic inflammation disease needed to chronic inflammation therapy
Childbearing and breast-feeding women
Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial
Subject who are judged unsuitable to participate in this study by investigator
No Results Posted