- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01878201
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 opdateret af: 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
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
75
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Seoul, Korea, Republikken, 110-744
- Seoul National University Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Fimasartan 30 mg
Take one capsule filled with a Fimasartan 30 mg in the every morning
|
Fimasartan 30 mg
Andre navne:
|
|
Aktiv komparator: Valsartan 80 mg
Take one capsule filled with a Valsartan 80 mg in the every morning
|
Valsartan 80 mg
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Systolic Blood Pressure during 24 hours
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Diastolic Blood Pressure during 24 hours
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 8 weeks from baseline visit
|
Smoothness index of systolic blood pressure and diastolic blood pressure measured by ABP monitor
|
8 weeks from baseline visit
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse events
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Byung-He Oh, professor, Seoul National University Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2013
Primær færdiggørelse (Faktiske)
1. februar 2014
Studieafslutning (Faktiske)
1. februar 2014
Datoer for studieregistrering
Først indsendt
31. maj 2013
Først indsendt, der opfyldte QC-kriterier
12. juni 2013
Først opslået (Skøn)
14. juni 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. september 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. september 2014
Sidst verificeret
1. september 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A657-BR-CT-L201
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Essentiel hypertension
-
CND Life SciencesNational Institute of Neurological Disorders and Stroke (NINDS)RekrutteringEssential Tremor | Essential Tremor-plus | Essentiel tremor, bevægelsesforstyrrelserForenede Stater
-
Emory UniversityAfsluttetEssential Tremor | Essential Vocal Tremor | Essential Voice Tremor | Stemme tremor | Vokal TremorForenede Stater
-
University of MinnesotaRekrutteringEssential Tremor | Essential Tremor i øvre ekstremiteterForenede Stater
-
Syracuse UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)AfsluttetEssential Voice Tremor | Stemme tremor | Vokal Tremor | Essential Tremor of VoiceForenede Stater
-
Xiangya Hospital of Central South UniversityTilmelding efter invitation
-
KU LeuvenIkke rekrutterer endnu
-
University of PennsylvaniaIkke rekrutterer endnu
-
University of FloridaRekrutteringEssential TremorForenede Stater
-
University Hospital, GenevaWyss Center for Bio and Neuroengineering; University of Geneva, SwitzerlandIkke rekrutterer endnuEssential TremorSchweiz
-
University of FloridaRekruttering
Kliniske forsøg med Fimasartan
-
Boryung Pharmaceutical Co., LtdYonsei University; Kyungpook National University HospitalAfsluttetEssentiel hypertension | Nedsat leverfunktionKorea, Republikken
-
Boryung Pharmaceutical Co., LtdAfsluttet
-
Boryung Pharmaceutical Co., LtdSeoul National University HospitalAfsluttet
-
Boryung Pharmaceutical Co., LtdSeoul National University Hospital; Kyungpook National University HospitalAfsluttet
-
Boryung Pharmaceutical Co., LtdCovanceAfsluttetEssentiel hypertension
-
Boryung Pharmaceutical Co., LtdChonbuk National University Hospital; Samsung Medical Center; Asan Medical... og andre samarbejdspartnereAfsluttetEssentiel hypertensionKorea, Republikken
-
Seoul National University HospitalSamsung Medical Center; Chonnam National University Hospital; Korea University... og andre samarbejdspartnereUkendtKritisk stenose af aortaklapKorea, Republikken
-
Boryung Pharmaceutical Co., LtdAfsluttetForhøjet blodtrykKorea, Republikken
-
Seoul National University Bundang HospitalAfsluttetForhøjet blodtryk | Venstre ventrikulær hypertrofi
-
Boryung Pharmaceutical Co., LtdAfsluttet