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

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878201
• Other study ID #: A657-BR-CT-L201
• Status: Completed
• Phase: Phase 2
• First received: May 31, 2013
• Last updated: September 5, 2014
• Start date: May 2013
• Est. completion date: February 2014

Study information

• Verified date: September 2014
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministy of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Fimasartan
Fimasartan 30 mg
• Valsartan
Valsartan 80 mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (7)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd	Asan Medical Center, Chonnam National University Hospital, Inje University, Kyungpook National University, Seoul National University Bundang Hospital, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Adverse evnt(AE)s are collected as a safety measure. All AEs are arranged based on severity, relevance to the investigational drug and serious adverse event each.	about 10~11weeks from placebo run-in visit	Yes
Other	Adverse changes in laboratory test results	Adverse changes in laboratory test results are collected as a safety measure. As a continuous data group for each test visit, adverse changes in laboratory test results present descriptive statistics (mean, standard deviation, minimum, maximum, etc.)	about 10~11weeks from screening visit	Yes
Other	Adverse changes in electrocardiography(ECG)	Adverse changes in ECG are collected as a safety measure. As a categorical data, adverse changes in ECG present frequency and percentage for each category.	about 10~11weeks from screening visit	Yes
Primary	Mean Systolic Blood Pressure during 24 hours	To compare the difference of Mean Systolic Blood Pressure during 24 hours at 8 weeks from baseline visit	8 weeks from baseline visit	No
Secondary	Mean Diastolic Blood Pressure during 24 hours	To compare the difference of Mean Diastolic Blood Pressure during 24 hours at 8 weeks from baseline visit	8 weeks from baseline visit	No
Secondary	Mean Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime	To compare the difference of Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime at 8 weeks from baseline visit	8 weeks from baseline visit	No
Secondary	Sitting Diastolic Blood pressure and Systolic Blood pressure	To compare the difference of Sitting Diastolic Blood pressure and Systolic Blood pressure at 8 weeks from baseline visit	8 weeks from baseline visit	No
Secondary	Trough-to-peak ratio	Trough-to-peak ratio of systolic blood pressure and diastolic blood pressure measured by ABP(Ambulatory Blood Pressure) monitor	8 weeks from baseline visit	No
Secondary	Smoothness index	Smoothness index of systolic blood pressure and diastolic blood pressure measured by ABP monitor	8 weeks from baseline visit	No