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

A Randomized, Double-Blind, Phase IV 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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Fimasartan; Drug: Atenolol

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hallym University Medical Center
  • Incheon, Korea, Republic of
    • Gachon University Gil Hospital
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Kangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fimasartan 60mg; 60mg/day of Fimasartan will be oral administered for the study period (8 weeks)	Drug: Fimasartan; Fimasartan 60mg; Other Names: Kanarb
Active Comparator: Atenolol 50mg; 50mg/day of Atenolol will be oral administered for the study period (8 weeks)	Drug: Atenolol; Atenolol 50mg; Other Names: Tenolmin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference of sitting Systolic Blood Pressure(SiSBP) between at the peak compared to at resting	To compare the difference of sitting Systolic Blood Pressure(SiSBP) at the peak compared to at resting between Fimasartan 60mg group and Atenolol 50mg group	After 8 weeks from baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference of sitting Diastolic Blood Pressure(SiDBP) at the peak compared to at resting	To compare the difference of sitting Diastolic Blood Pressure(SiDBP), Heart Rate, Neurohormonal markers at the peak compared to at resting between Fimasartan 60mg group and Atenolol 50mg group	After 8 weeks from baseline visit
The difference of sitting Systolic Blood Pressure(SiSBP) at each exercising stage compared to at resting	To compare the difference of sitting Systolic Blood Pressure(SiSBP), sitting Diastolic Blood Pressure(SiDBP), Heart Rate at each exercising stage and at recovery compared to at resting between Fimasartan 60mg group and Atenolol 50mg group	After 8 weeks from baseline visit
The difference of sitting Systolic Blood Pressure(SiSBP) among at resting, each exercising stage and recovery	To compare the difference of sitting Systolic Blood Pressure(SiSBP), sitting Diastolic Blood Pressure(SiDBP), Heart Rate, neurohormonal markers among at resting, each exercising stage and recovery between Fimasartan 60mg group and Atenolol 50mg group	After 8 weeks from baseline visit

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborators: Severance Hospital
• Investigators: Principal Investigator: Jong Won Ha, PhD, Yonsei University

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 19, 2012
• First Submitted That Met QC Criteria: November 26, 2012
• First Posted (Estimate): November 29, 2012

Study Record Updates

• Last Update Posted (Estimate): September 23, 2016
• Last Update Submitted That Met QC Criteria: September 21, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Exercise; Hypertension; Antihypertensive efficacy; Neurohormonal markers; Blood Pressure Response
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Atenolol
• Other Study ID Numbers: BR-FA-CT-401