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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
Conditie
Interventie / Behandeling
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
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-
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Seoul, Korea, republiek van, 110-744
- Seoul National University Hospital
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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:
- 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
Exclusion Criteria:
- 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)
- Patients with depletion of body fluid or sodium ion not able to correct
- Patients with suspected or history of drug or alcohol abuse within the past two years
- 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
- Patients with any chronic inflammation disease needed to chronic inflammation therapy
- Patients with hepatitis type B or type C and carriers
- Patients with laboratory test results indicating clinically significant abnormal results
- Patients receiving medication that can affect blood pressure
- Patients with history of allergic reaction to any angiotensin II antagonist
- Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin
- Patients who took investigational drug within 12 weeks from screening visit or is going on the progress of other clinical trial
- 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
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Fimasartan 30 mg
Andere namen:
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Actieve vergelijker: Valsartan 80 mg
Take one capsule filled with a Valsartan 80 mg in the every morning
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Valsartan 80 mg
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mean Systolic Blood Pressure during 24 hours
Tijdsspanne: 8 weeks from baseline visit
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To compare the difference of Mean Systolic Blood Pressure during 24 hours at 8 weeks from baseline visit
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8 weeks from baseline visit
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Mean Diastolic Blood Pressure during 24 hours
Tijdsspanne: 8 weeks from baseline visit
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To compare the difference of Mean Diastolic Blood Pressure during 24 hours at 8 weeks from baseline visit
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8 weeks from baseline visit
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Mean Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime
Tijdsspanne: 8 weeks from baseline visit
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To compare the difference of Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime at 8 weeks from baseline visit
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8 weeks from baseline visit
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Sitting Diastolic Blood pressure and Systolic Blood pressure
Tijdsspanne: 8 weeks from baseline visit
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To compare the difference of Sitting Diastolic Blood pressure and Systolic Blood pressure at 8 weeks from baseline visit
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8 weeks from baseline visit
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Trough-to-peak ratio
Tijdsspanne: 8 weeks from baseline visit
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Trough-to-peak ratio of systolic blood pressure and diastolic blood pressure measured by ABP(Ambulatory Blood Pressure) monitor
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8 weeks from baseline visit
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Smoothness index
Tijdsspanne: 8 weeks from baseline visit
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Smoothness index of systolic blood pressure and diastolic blood pressure measured by ABP monitor
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8 weeks from baseline visit
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Adverse events
Tijdsspanne: about 10~11weeks from placebo run-in visit
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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.
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about 10~11weeks from placebo run-in visit
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Adverse changes in laboratory test results
Tijdsspanne: about 10~11weeks from screening visit
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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.)
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about 10~11weeks from screening visit
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Adverse changes in electrocardiography(ECG)
Tijdsspanne: about 10~11weeks from screening visit
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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.
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about 10~11weeks from screening visit
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Byung-He Oh, professor, Seoul National University Hospital
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
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- A657-BR-CT-L201
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 .