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Safety and Tolerability and Efficacy of LCZ696 in Japanese Severe Hypertensive Patients

2. oktober 2015 opdateret af: Novartis Pharmaceuticals

A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Patients With Severe Hypertension

This study assessed the safety, tolerability, and efficacy of LCZ696 in severe hypertensive Japanese patients

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Summaries for treatment-emergent adverse events, serious adverse events and death were provided by the following actual treatment regimen (actual treatment patients received) in addition to all patients: LCZ696 200mg, 400mg, 400mg+other hypertensive medications.

Summaries for others than above were provided by the following treatment regimen (determined by the maximal treatment patients received) in addition to all patients: LCZ696 200mg, 400mg, 400mg+other hypertensive medications.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

35

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
    • Kanagawa
      • Yokohama-city, Kanagawa, Japan, 231-0023
        • Novartis Investigative Site
    • Kyoto
      • Kyoto-city, Kyoto, Japan, 606-8507
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-0031
        • Novartis Investigative Site
      • Hachioji-city, Tokyo, Japan, 192-0918
        • Novartis Investigative Site
      • Minato-ku, Tokyo, Japan, 105-7390
        • Novartis Investigative Site
      • Minato-ku, Tokyo, Japan, 108-0075
        • Novartis Investigative Site
      • Ota-ku, Tokyo, Japan, 143-0023
        • Novartis Investigative Site
      • Shibuya-ku, Tokyo, Japan, 150-0002
        • Novartis Investigative Site
      • Shinagawa-ku, Tokyo, Japan, 141-0032
        • Novartis Investigative Site

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Satisfy office msSBP ≥180 mmHg or office msDBP ≥110 mmHg at baseline

Exclusion Criteria:

  • Patients show msSBP ≥220 mmHg and/or msDBP ≥120 mmHg
  • History of angioedema, drug-related or otherwise, as reported by the patient
  • Patients unwilling or not able to discontinue safely the use of current antihypertensive medications during the study, as required by the protocol.
  • Patients have significant cardiovascular co-morbidities
  • Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.

Other protocol defined inclusion/exclusion criteria may apply.

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: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: LCZ696 200 mg
All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
Medicin: LCZ696
LCZ696 200 mg tablet once daily
Medicin: LCZ696
2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily
Medicin: LCZ696
2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily plus other HTN medications
Eksperimentel: LCZ696 400 mg
All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
Medicin: LCZ696
LCZ696 200 mg tablet once daily
Medicin: LCZ696
2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily
Medicin: LCZ696
2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily plus other HTN medications
Eksperimentel: LCZ696 400 mg plus other hypertension (HTN) medications
All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
Medicin: LCZ696
LCZ696 200 mg tablet once daily
Medicin: LCZ696
2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily
Medicin: LCZ696
2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily plus other HTN medications

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths
Tidsramme: Week 8
Adverse events, serious adverse events deaths were monitored from screening to week 8.
Week 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in msSBP and msDBP at Week 8
Tidsramme: Baseline, 8 weeks
Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP measurements were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline value.
Baseline, 8 weeks
Percentage of Participants With Successful Blood Pressure (BP) Control in msSBP/msDBP at End of Study
Tidsramme: 8 weeks
Successful BP control in patients with severe hypertension at the end of study treatment was defined as follows: msSBP/msDBP< 140/90 mmHg.
8 weeks
Percentage of Participants Achieving Successful msSBP Control at End of Study
Tidsramme: 8 weeks
Successful msSBP control in patients with severe hypertension at the end of study treatment was defined as msSBP <140 mmHg.
8 weeks
Percentage of Participants Achieving Successful msDBP Control at End of Study
Tidsramme: 8 weeks
Successful msDBP control in patients with severe hypertension at the end of study treatment was defined as msDBP < 90 mmHg.
8 weeks
Percentage of Participants With SBP Response at End of Study
Tidsramme: Baseline, 8 weeks
SBP response was defined as <140 mmHg or a reduction ≥ 20 mmHg from baseline.
Baseline, 8 weeks
Percentage of Participants With DBP Response at End of Study
Tidsramme: Baseline, 8 weeks
DBP response was defined as <90 mmHg or a reduction ≥ 10 mmHg from baseline.
Baseline, 8 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

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. juli 2012

Primær færdiggørelse (Faktiske)

1. februar 2013

Studieafslutning (Faktiske)

1. februar 2013

Datoer for studieregistrering

Først indsendt

18. juli 2012

Først indsendt, der opfyldte QC-kriterier

18. juli 2012

Først opslået (Skøn)

20. juli 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CLCZ696A1305

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Kliniske forsøg med Severe Hypertension

Kliniske forsøg med LCZ696

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gambia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner