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

NCT01736488 | Completed Phase 4

• 1 other identifier: BR-FA-CT-401
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

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.

Conditions

Hypertension

Keywords

Hypertension; Antihypertensive efficacy; Neurohormonal markers; Blood Pressure Response; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The difference of sitting Diastolic Blood Pressure(SiDBP) at the peak compared to at resting

  After 8 weeks from baseline visit

• The difference of sitting Systolic Blood Pressure(SiSBP) at each exercising stage compared to at resting

  After 8 weeks from baseline visit

• The difference of sitting Systolic Blood Pressure(SiSBP) among at resting, each exercising stage and recovery

  After 8 weeks from baseline visit

Study Arms (2)

Fimasartan 60mg

EXPERIMENTAL

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

Drug: Fimasartan

Atenolol 50mg

ACTIVE COMPARATOR

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

Drug: Atenolol

Interventions

Fimasartan DRUG

Fimasartan 60mg

Also known as: Kanarb

Fimasartan 60mg

Atenolol DRUG

Atenolol 50mg

Also known as: Tenolmin

Atenolol 50mg

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who agreed to participate in this clinical trial and submitted the written informed consent
• Subjects aged 20 to 75 years
• 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)
• men who are measured more 210mmHg, women who are measured more 190mmHg or increasing more than 50mmHg after exercise at baseline(Day 0)
• Subject who considered to understand this clinical trial, be cooperative,and able to be followed-up whole of the clinical trial period

You may not qualify if:

• 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
• 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)
• Patients with secondary hypertension
• Patients with orthostatic hypotension who has sign and symptom
• Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c\>9, regimen change of oral hypoglycemic agent, using insulin)
• Patients with severe heart disease, ischemic heart disease within 6 months, peripheral vascular disease, Percutaneous transluminal coronary angiography(PTCA), Coronary artery bypass graft(CABG)
• Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
• Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
• Patients with severe cerebrovascular disease
• Patients with known severe or malignancy retinopathy
• Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous
• 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
• Patients with surgical and medical disease that is able to be affect to absorption, distribution, metabolism and excretion
• Patients who have a story or evidence of alcohol or drug abuse within 2 years
• Childbearing and breast-feeding women

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead
• Severance Hospital: collaborator

Study Sites (4)

Hallym University Medical Center

Anyang, South Korea

Location

Gachon University Gil Hospital

Incheon, South Korea

Location

Severance Hospital

Seoul, 120-752, South Korea

Location

Kangnam Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension; Motor Activity

Interventions

fimasartan; Atenolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Jong Won Ha, PhD

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 29, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2016
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

KR (4)