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Efficacy, Safety and Pharmacodynamic/Pharmacokinetic Study of Fimasartan (BR-A-657•K) (Fimasartan)

10. juli 2009 opdateret af: Boryung Pharmaceutical Co., Ltd

Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Antihypertensive Efficacy, Safety, Tolerability, and Pharmacodynamic/Pharmacokinetic Profiles After 4 Weeks of Oral Administration of Fimasartan(BR-A-657) at 20-180mg in Patients With Essential Hypertension

Study objective:

  1. To evaluate the antihypertensive efficacy, safety and tolerability of the drug after the oral administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential hypertension.
  2. To review the pharmacokinetic profile after the multiple administration and the pharmacodynamic profile regarding the renin-angiotensin system, after the oral administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential hypertension.
  3. To determine the dose for the clinical study at the next phase by analyzing the relationship between the antihypertensive efficacy and pharmacokinetic • pharmacodynamic results.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan (BR-A-657-K) 20mg ~ 480mg single dosing with healthy subjects, demonstrated that the Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose.

A randomized, double-blind, placebo-controlled, parallel grouped, clinical study will be conducted to evaluate the antihypertensive efficacy and tolerability and to determine adequate antihypertensive dosage of Fimasartan(BR-A-657-K) in patients with mild to moderate essential hypertension.

Approximately 60 patients will be enrolled over 12 months in Seoul National University Hospital.

After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 5 groups. Subjects will take test drug/placebo for 28 days of treatment period. If subjects take any antihypertensive medications before screening, the subjects will have 1 week of wash-out period.

Group I : Placebo, Group II : Fimasartan 20 mg, Group III: Fimasartan 60 mg, Group IV : Fimasartan 180 mg

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

81

Fase

  • Fase 2

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

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adult men and women, aged 18 - 65
  • Patients with mild to moderate essential hypertension: On both screening and Day -1 visit, mean sitting DBP should be ≥ 95mmHg and ≤ 114mmHg, and ΔDBP on Day -14 and Day -1 should be within 7 mmHg
  • Patients who gave their consent to participate in this study and signed the written informed consent form
  • Patients who have understood the study, and been judged to be cooperative and able to participate in the study until the study completion date

Exclusion Criteria:

  1. Women of childbearing potential who have not received the hysterectomy or men who are not willing to use birth control measures.
  2. Patients whose sitting DBP is < 95mmHg or ≥ 115mmHg. Patients with severe hypertension whose SBP is ≥200mmHg
  3. Patients with secondary hypertension
  4. Patients with severe renal disease, gastrointestinal disorder, hematologic disorder, liver disease, etc. that can affect the absorption, distribution, metabolism and excretion of drugs
  5. Patients with symptoms of orthostatic hypotension
  6. Patients with severe insulin dependent diabetes or uncontrolled diabetes
  7. Patients who suffered myocardial infarction or serious coronary arterial disease over the past 6 months or patients with clinically significant congestive heart failure or valvular heart disease
  8. Patients with consumption disease, autoimmune disease, or connective tissue disease
  9. Patients with the history of type B hepatitis or type C hepatitis
  10. Patients with HIV infection or hepatitis
  11. Patients with clinically significant abnormal laboratory test findings
  12. Patients on any drug treatment that might affect the blood pressure
  13. Patients with allergy or contraindication to angiotensin II-receptor antagonists
  14. Patients with current or suspected alcohol addiction or history of drug abuse
  15. Patients whose mean weight lies out of the range of -15% ~ +35%, based on the Modified Metropolitan Life Insurance table
  16. Patients who are not eligible as subjects of the study, as determined by the principal investigator or a sub-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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Placebo, 3 tablets
Medicin: Placebo
Placebo
Aktiv komparator: BR-A-657•K 20 mg group
Fimasartan 20 mg, 1 tablet + placebo, 2 tablets
Medicin: Fimasartan (BR-A-657•K) 20 mg
Fimasartan 20 mg, 1 tablet + placebo, 2 tablets
Andre navne:
  • Fimasartan
Aktiv komparator: BR-A-657•K 60 mg group
Fimasartan 20 mg, 1 tablet + 40 mg, 1 tablet + placebo 1 tablet
Medicin: Fimasartan (BR-A-657•K) 60 mg
Fimasartan 20 mg, 1 tablet + 40 mg, 1 tablet + placebo 1 tablet
Andre navne:
  • Fimasartan
Aktiv komparator: BR-A-657•K 180 mg group
Fimasartan 20 mg, 1 tablet + 80 mg, 1 tablet + 80 mg 1 tablet
Medicin: Fimasartan (BR-A-657•K) 180 mg
Fimasartan 20 mg, 1 tablet + 80 mg, 1 tablet + 80 mg 1 tablet
Andre navne:
  • Fimasartan

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
the level of sitting diastolic blood pressure reduction
Tidsramme: Day -1 vs Day 27
Day -1 vs Day 27

Sekundære resultatmål

Resultatmål
Tidsramme
the level of sitting systolic blood pressure reduction, mean blood pressure (MBP), 24-hr day-time, night-time SBP and DBP, T/P ratio based on the 24-hr Ambulatory Blood Pressure Monitoring
Tidsramme: Day -1 vs Day 27
Day -1 vs Day 27

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boryung Pharmaceutical Co., Ltd

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. april 2005

Primær færdiggørelse (Faktiske)

1. juni 2006

Studieafslutning (Faktiske)

1. juni 2006

Datoer for studieregistrering

Først indsendt

10. juli 2009

Først indsendt, der opfyldte QC-kriterier

10. juli 2009

Først opslået (Skøn)

13. juli 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. juli 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juli 2009

Sidst verificeret

1. juli 2009

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A657-BR-CT-201

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

Kliniske forsøg med Placebo

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