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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 oppdatert av: 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

Studieoversikt

Status

Fullført

Studietype

Intervensjonell

Registrering (Faktiske)

75

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Seoul, Korea, Republikken, 110-744
        • Seoul National University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Fimasartan 30 mg
Take one capsule filled with a Fimasartan 30 mg in the every morning
Fimasartan 30 mg
Andre navn:
  • Kanarb
Aktiv komparator: Valsartan 80 mg
Take one capsule filled with a Valsartan 80 mg in the every morning
Valsartan 80 mg
Andre navn:
  • Diovan

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2013

Primær fullføring (Faktiske)

1. februar 2014

Studiet fullført (Faktiske)

1. februar 2014

Datoer for studieregistrering

Først innsendt

31. mai 2013

Først innsendt som oppfylte QC-kriteriene

12. juni 2013

Først lagt ut (Anslag)

14. juni 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

8. september 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. september 2014

Sist bekreftet

1. september 2014

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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