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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

5 september 2014 bijgewerkt door: Boryung Pharmaceutical Co., Ltd

A Randomized, Double-blind, Valsartan 80 Mg-Referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan 30 mg During 24 Hours in Patients With Mild to Moderate Essential Hypertension

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

Studie Overzicht

Toestand

Voltooid

Studietype

Ingrijpend

Inschrijving (Werkelijk)

75

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Subjects aged 20 to 70 years
  2. 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)
  3. Subjects who agreed to participate in this study and submitted the written informed consent
  4. Subjects who considered to understand this study, be cooperative, and able to be followed-up whole of the study period

Exclusion Criteria:

  1. 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)
  2. Patients with difference of office BP at selected one arm over DBP 10 mmHg and/or SBP 20 mmHg at screening visit
  3. Patients with secondary hypertension
  4. Patients with symptomatic orthostatic hypotension
  5. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, increased regimen of oral hypoglycemic agent, using insulin at baseline visit)
  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 within 6 months
  10. Patients with known severe or malignancy retinopathy within 6 months
  11. Patients with wasting disease, autoimmune disease, connective tissue disease
  12. 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)
  13. Patients with surgical or medical disease which is able to be affect to absorption, distribution, metabolism, excretion
  14. Patients with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  15. Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
  16. Patients with depletion of body fluid or sodium ion not able to correct
  17. Patients with suspected or history of drug or alcohol abuse within the past two years
  18. Childbearing, breast-feeding women and female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
  19. Patients with any chronic inflammation disease needed to chronic inflammation therapy
  20. Patients with hepatitis type B or type C and carriers
  21. Patients with laboratory test results indicating clinically significant abnormal results
  22. Patients receiving medication that can affect blood pressure
  23. Patients with history of allergic reaction to any angiotensin II antagonist
  24. Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin
  25. Patients who took investigational drug within 12 weeks from screening visit or is going on the progress of other clinical trial
  26. Subject who are judged unsuitable to participate in this study by investigator

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Fimasartan 30 mg
Take one capsule filled with a Fimasartan 30 mg in the every morning
Fimasartan 30 mg
Andere namen:
  • Kanarb
Actieve vergelijker: Valsartan 80 mg
Take one capsule filled with a Valsartan 80 mg in the every morning
Valsartan 80 mg
Andere namen:
  • Diovan

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Systolic Blood Pressure during 24 hours
Tijdsspanne: 8 weeks from baseline visit
To compare the difference of Mean Systolic Blood Pressure during 24 hours at 8 weeks from baseline visit
8 weeks from baseline visit

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Diastolic Blood Pressure during 24 hours
Tijdsspanne: 8 weeks from baseline visit
To compare the difference of Mean Diastolic Blood Pressure during 24 hours at 8 weeks from baseline visit
8 weeks from baseline visit
Mean Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime
Tijdsspanne: 8 weeks from baseline visit
To compare the difference of Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime at 8 weeks from baseline visit
8 weeks from baseline visit
Sitting Diastolic Blood pressure and Systolic Blood pressure
Tijdsspanne: 8 weeks from baseline visit
To compare the difference of Sitting Diastolic Blood pressure and Systolic Blood pressure at 8 weeks from baseline visit
8 weeks from baseline visit
Trough-to-peak ratio
Tijdsspanne: 8 weeks from baseline visit
Trough-to-peak ratio of systolic blood pressure and diastolic blood pressure measured by ABP(Ambulatory Blood Pressure) monitor
8 weeks from baseline visit
Smoothness index
Tijdsspanne: 8 weeks from baseline visit
Smoothness index of systolic blood pressure and diastolic blood pressure measured by ABP monitor
8 weeks from baseline visit

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adverse events
Tijdsspanne: about 10~11weeks from placebo run-in visit
Adverse evnt(AE)s are collected as a safety measure. All AEs are arranged based on severity, relevance to the investigational drug and serious adverse event each.
about 10~11weeks from placebo run-in visit
Adverse changes in laboratory test results
Tijdsspanne: about 10~11weeks from screening visit
Adverse changes in laboratory test results are collected as a safety measure. As a continuous data group for each test visit, adverse changes in laboratory test results present descriptive statistics (mean, standard deviation, minimum, maximum, etc.)
about 10~11weeks from screening visit
Adverse changes in electrocardiography(ECG)
Tijdsspanne: about 10~11weeks from screening visit
Adverse changes in ECG are collected as a safety measure. As a categorical data, adverse changes in ECG present frequency and percentage for each category.
about 10~11weeks from screening visit

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2013

Primaire voltooiing (Werkelijk)

1 februari 2014

Studie voltooiing (Werkelijk)

1 februari 2014

Studieregistratiedata

Eerst ingediend

31 mei 2013

Eerst ingediend dat voldeed aan de QC-criteria

12 juni 2013

Eerst geplaatst (Schatting)

14 juni 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

8 september 2014

Laatste update ingediend die voldeed aan QC-criteria

5 september 2014

Laatst geverifieerd

1 september 2014

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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