Clinical Study to Evaluate the Antihypertensive Efficacy and Changes of Neurohormonal Markers of Fimasartan and Atenolol With Exaggerated Blood Pressure Response During Exercise in Essential Hypertensive Patients

NCT ID: NCT01736488

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31

Brief Summary

The purpose of this study is to evaluate the antihypertensive efficacy and changes of neurohormonal markers of fimasartan and atenolol with exaggerated blood pressure response during exercise in essential hypertensive patients.

Detailed Description

After subjects have signed informed consent voluntarily, when they are taking hypertension medication, they go through screening period for 7 days including wash-out period.

After screening and wash-out period, subjects take the placebo for 14 days (Maximum 21 days), and evaluate their suitability to Inclusion and Exclusion criteria.

Patients, who evaluated the proper subject for this clinical trial, are allocated to experimental group (Fimasartan 60mg) or Control group (Atenolol 50mg) randomly at a ratio 1:1 and their investigational drugs will be administered daily for the study period (8 weeks). Subjects visit their investigators twice during treatment period, when they take their investigational drugs for 4 weeks, and 8 weeks.

The placebo period will be single-blinded and the treatment allocation in this study will be double-blinded.

Conditions

Hypertension

Study Design

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

Study Groups

Fimasartan 60mg

60mg/day of Fimasartan will be oral administered for the study period (8 weeks)

Group Type: EXPERIMENTAL

Fimasartan

Intervention Type: DRUG

Fimasartan 60mg

Atenolol 50mg

50mg/day of Atenolol will be oral administered for the study period (8 weeks)

Group Type: ACTIVE_COMPARATOR

Atenolol

Intervention Type: DRUG

Atenolol 50mg

Interventions

Fimasartan

Fimasartan 60mg

Intervention Type: DRUG

Atenolol

Atenolol 50mg

Intervention Type: DRUG

Other Intervention Names

Kanarb; Tenolmin

Eligibility Criteria

Inclusion Criteria

1. Subjects who agreed to participate in this clinical trial and submitted the written informed consent

2. Subjects aged 20 to 75 years

3. Essential hypertension patients who are measured more 140mmHg, less than 170mmHg of sitting systolic blood pressure(SiSBP) or more 90mmHg, less than 110mmHg of sitting diastolic blood pressure(SiDBP) at baseline(Day 0)

4. men who are measured more 210mmHg, women who are measured more 190mmHg or increasing more than 50mmHg after exercise at baseline(Day 0)

5. Subject who considered to understand this clinical trial, be cooperative,and able to be followed-up whole of the clinical trial period

Exclusion Criteria

1. Patients who are measured the difference of mean blood pressure of one arm under sitting diastolic blood pressure(SiDBP) 10mmHg or SiSBP 20mmHg at screening and baseline visit

2. more 170mmHg of mean Sitting systolic blood pressure(SiSBP)or more 110mmHg of mean Sitting diastolic blood pressure(SiDBP) before exercise at baseline(Day 0)

3. Patients with secondary hypertension

4. Patients with orthostatic hypotension who has sign and symptom

5. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c>9, regimen change of oral hypoglycemic agent, using insulin)

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

10. Patients with known severe or malignancy retinopathy

11. Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous

12. Patients with significant investigations; abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function(AST, ALT more 2 times than upper limit of normal), severe fatty liver disease needed medication

13. Patients with surgical and medical disease that is able to be affect to absorption, distribution, metabolism and excretion

14. Patients who have a story or evidence of alcohol or drug abuse within 2 years

15. Childbearing and breast-feeding women

16. Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods

17. Patients with Bronchial Asthma

18. Patients expected to live less than 1 year with tumor or chronic disease

19. Patients with hepatitis B or C

20. Patients with history of allergic reaction to any angiotensin II antagonist

21. Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial

22. Subject who are judged unsuitable to participate in this clinical trial by investigator

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Severance Hospital

OTHER

Sponsor Role: collaborator

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jong Won Ha, PhD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

Hallym University Medical Center

Anyang, , South Korea

Gachon University Gil Hospital

Incheon, , South Korea

Severance Hospital

Seoul, , South Korea

Kangnam Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BR-FA-CT-401

Identifier Type: -

Identifier Source: org_study_id