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

NCT ID: NCT01878201

Last Updated: 2014-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-02-28

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

Conditions

Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fimasartan 30 mg

Take one capsule filled with a Fimasartan 30 mg in the every morning

Group Type: EXPERIMENTAL

Fimasartan

Intervention Type: DRUG

Fimasartan 30 mg

Valsartan 80 mg

Take one capsule filled with a Valsartan 80 mg in the every morning

Group Type: ACTIVE_COMPARATOR

Valsartan

Intervention Type: DRUG

Valsartan 80 mg

Interventions

Fimasartan

Fimasartan 30 mg

Intervention Type: DRUG

Valsartan

Valsartan 80 mg

Intervention Type: DRUG

Other Intervention Names

Kanarb; Diovan

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role: collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role: collaborator

Chonnam National University Hospital

OTHER

Sponsor Role: collaborator

Inje University

OTHER

Sponsor Role: collaborator

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Byung-He Oh, professor

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

A657-BR-CT-L201

Identifier Type: -

Identifier Source: org_study_id