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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Boryung Pharmaceutical Co., Ltd
Sponsor:
Collaborator:
Severance Hospital
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01736488
First received: November 19, 2012
Last updated: May 28, 2013
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Fimasartan
Drug: Atenolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boryung Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • The difference of sitting Systolic Blood Pressure(SiSBP) between at the peak compared to at resting [ Time Frame: After 8 weeks from baseline visit ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • The difference of sitting Diastolic Blood Pressure(SiDBP) at the peak compared to at resting [ Time Frame: After 8 weeks from baseline visit ] [ Designated as safety issue: Yes ]
    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

  • The difference of sitting Systolic Blood Pressure(SiSBP) at each exercising stage compared to at resting [ Time Frame: After 8 weeks from baseline visit ] [ Designated as safety issue: Yes ]
    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

  • The difference of sitting Systolic Blood Pressure(SiSBP) among at resting, each exercising stage and recovery [ Time Frame: After 8 weeks from baseline visit ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 72
Study Start Date: October 2012
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fimasartan 60mg
60mg/day of Fimasartan will be oral administered for the study period (8 weeks)
Drug: Fimasartan
Fimasartan 60mg
Other Name: Kanarb
Active Comparator: Atenolol 50mg
50mg/day of Atenolol will be oral administered for the study period (8 weeks)
Drug: Atenolol
Atenolol 50mg
Other Name: Tenolmin

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736488

Contacts
Contact: Seong Hee Lee, Director +82-2-708-8069 shlee07@boryung.co.kr
Contact: Min Lee Kim, CRA +82-2-708-8065 kminlee@boryung.co.kr

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sun Kyung Kang, CRC    +82-2-2228-8229    sk2ang@yuhs.ac   
Principal Investigator: Jong Won Ha, PhD         
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Severance Hospital
Investigators
Principal Investigator: Jong Won Ha, PhD Yonsei University
  More Information

No publications provided

Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01736488     History of Changes
Other Study ID Numbers: BR-FA-CT-401
Study First Received: November 19, 2012
Last Updated: May 28, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Boryung Pharmaceutical Co., Ltd:
Hypertension
Antihypertensive efficacy
Neurohormonal markers
Blood Pressure Response
Exercise

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Atenolol
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014