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

NCT01878201 | Completed Phase 2 DMC

• 1 other identifier: A657-BR-CT-L201
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

Fimasartan; 24 hours ABP monitoring(ABPM); antihypertension

Outcome Measures

Primary Outcomes (1)

• Mean Systolic Blood Pressure during 24 hours

  To compare the difference of Mean Systolic Blood Pressure during 24 hours at 8 weeks from baseline visit

  8 weeks from baseline visit

Secondary Outcomes (5)

• Mean Diastolic Blood Pressure during 24 hours

  8 weeks from baseline visit

• Mean Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime

  8 weeks from baseline visit

• Sitting Diastolic Blood pressure and Systolic Blood pressure

  8 weeks from baseline visit

• Trough-to-peak ratio

  8 weeks from baseline visit

• Smoothness index

  8 weeks from baseline visit

Other Outcomes (3)

• Adverse events

  about 10~11weeks from placebo run-in visit

• Adverse changes in laboratory test results

  about 10~11weeks from screening visit

• Adverse changes in electrocardiography(ECG)

  about 10~11weeks from screening visit

Study Arms (2)

Fimasartan 30 mg

EXPERIMENTAL

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

Drug: Fimasartan

Valsartan 80 mg

ACTIVE COMPARATOR

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

Drug: Valsartan

Interventions

Fimasartan DRUG

Fimasartan 30 mg

Also known as: Kanarb

Fimasartan 30 mg

Valsartan DRUG

Valsartan 80 mg

Also known as: Diovan

Valsartan 80 mg

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 20 to 70 years
• 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)
• Subjects who agreed to participate in this study and submitted the written informed consent
• Subjects who considered to understand this study, be cooperative, and able to be followed-up whole of the study period

You may not qualify if:

• 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)
• Patients with difference of office BP at selected one arm over DBP 10 mmHg and/or SBP 20 mmHg at screening visit
• Patients with secondary hypertension
• Patients with symptomatic orthostatic hypotension
• Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c \> 9%, increased regimen of oral hypoglycemic agent, using insulin at baseline visit)
• 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 within 6 months
• Patients with known severe or malignancy retinopathy within 6 months
• Patients with wasting disease, autoimmune disease, connective tissue disease
• 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)
• Patients with surgical or medical disease which is able to be affect to absorption, distribution, metabolism, excretion
• Patients with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead
• Seoul National University Hospital: collaborator
• Asan Medical Center: collaborator
• Seoul National University Bundang Hospital: collaborator
• Kyungpook National University Hospital: collaborator
• Chonnam National University Hospital: collaborator
• Inje University: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

fimasartan; Valsartan

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Byung-He Oh, professor

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 14, 2013
• Study Start: May 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: September 8, 2014

Record last verified: 2014-09

Locations

KR (1)