Clinical trial NCT01878201: A Valsartan 80 Mg-Referenced, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan 30 mg During 24 Hours in Patients With Mild to Moderate Essential Hypertension
Official title: A Randomized, Double-blind, Valsartan 80 Mg-Referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan 30 mg During 24 Hours in Patients With Mild to Moderate Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Essential Hypertension
Keywords: Fimasartan
24 hours ABP monitoring(ABPM)
antihypertension
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Hospital
name: Asan Medical Center
name: Seoul National University Bundang Hospital
name: Kyungpook National University Hospital
name: Chonnam National University Hospital
name: Inje University
First posted: 2013-06-14
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to Evaluate the Antihypertensive efficacy of Fimasartan 30 mg during 24 hours in Patients with Mild to Moderate Essential Hypertension


Eligibility criteria: Inclusion Criteria:

1. Subjects aged 20 to 70 years
2. Essential hypertension subjects who are measured more 135/85 mmHg of average Diastolic Blood pressure (DBP) and Systolic Blood pressure (SBP) measured by ABP monitor at baseline visit(day 0)
3. Subjects who agreed to participate in this study and submitted the written informed consent
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 180 mmHg of mean sitting SBP and/or more 110 mmHg of mean sitting DBP measured as an office Blood pressure (BP), before Randomization (Screening visit, Placebo run-in visit, Pre-Baseline visit, Baseline visit)
2. Patients with difference of office BP at selected one arm over DBP 10 mmHg and/or SBP 20 mmHg at screening visit
3. Patients with secondary hypertension
4. Patients with symptomatic orthostatic hypotension
5. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c \> 9%, increased regimen of oral hypoglycemic agent, using insulin at baseline visit)
6. Patients with severe heart disease, ischemic heart disease within 6 months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
7. Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
8. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
9. Patients with severe cerebrovascular disease within 6 months
10. Patients with known severe or malignancy retinopathy within 6 months
11. Patients with wasting disease, autoimmune disease, connective tissue disease
12. Patients with significant investigations - abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function (Aspartate Transaminase(AST), Alanine Transaminase(ALT) more 2 times than upper normal)
13. Patients with surgical or medical disease which is able to be affect to absorption, distribution, metabolism, excretion
14. Patients with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
15. Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
16. Patients with depletion of body fluid or sodium ion not able to correct
17. Patients with suspected or history of drug or alcohol abuse within the past two years
18. Childbearing, breast-feeding women and female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
19. Patients with any chronic inflammation disease needed to chronic inflammation therapy
20. Patients with hepatitis type B or type C and carriers
21. Patients with laboratory test results indicating clinically significant abnormal results
22. Patients receiving medication that can affect blood pressure
23. Patients with history of allergic reaction to any angiotensin II antagonist
24. Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin
25. Patients who took investigational drug within 12 weeks from screening visit or is going on the progress of other clinical trial
26. Subject who are judged unsuitable to participate in this study by investigator

Primary outcomes:
measure: Mean Systolic Blood Pressure during 24 hours
timeFrame: 8 weeks from baseline visit
Secondary outcomes:
measure: Mean Diastolic Blood Pressure during 24 hours
timeFrame: 8 weeks from baseline visit
measure: Mean Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime
timeFrame: 8 weeks from baseline visit
measure: Sitting Diastolic Blood pressure and Systolic Blood pressure
timeFrame: 8 weeks from baseline visit
measure: Trough-to-peak ratio
timeFrame: 8 weeks from baseline visit
measure: Smoothness index
timeFrame: 8 weeks from baseline visit
Other outcomes:
measure: Adverse events
timeFrame: about 10~11weeks from placebo run-in visit
measure: Adverse changes in laboratory test results
timeFrame: about 10~11weeks from screening visit
measure: Adverse changes in electrocardiography(ECG)
timeFrame: about 10~11weeks from screening visit
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Byung-He Oh, professor
role: STUDY_CHAIR
References: