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Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients (AQUARIUS)

20. maj 2014 opdateret af: Novartis Pharmaceuticals

A 104 Week, Randomized, Double Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy of Aliskiren on the Progression of Atherosclerosis in Patients With Coronary Artery Disease When Added to Optimal Background Therapy

The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

613

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1428DCO
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1039AAP
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1280AEB
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1426ANZ
        • Novartis Investigative Site
      • Buenos aires, Argentina, C1210AAP
        • Novartis Investigative Site
      • Corrientes, Argentina, 3400
        • Novartis Investigative Site
    • Capital Federal
      • Buenos Aires, Capital Federal, Argentina, C1180AAX
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, C2000DSR
        • Novartis Investigative Site
  • Australien
    • New South Wales
      • Camperdown, New South Wales, Australien, 2050
        • Novartis Investigative Site
      • Liverpool, New South Wales, Australien, 2170
        • Novartis Investigative Site
      • New Lambton Heights, New South Wales, Australien, 2305
        • Novartis Investigative Site
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Novartis Investigative Site
    • Victoria
      • Clayton, Victoria, Australien, 3168
        • Novartis Investigative Site
  • Belgien
      • Aalst, Belgien, 9300
        • Novartis Investigative Site
      • Anderlecht, Belgien, 1070
        • Novartis Investigative Site
      • Brussel, Belgien, 1000
        • Novartis Investigative Site
      • Bruxelles, Belgien, 1200
        • Novartis Investigative Site
      • Charleroi, Belgien, 6000
        • Novartis Investigative Site
      • Genk, Belgien, 3600
        • Novartis Investigative Site
      • Ottignies, Belgien, 1340
        • Novartis Investigative Site
  • Canada
      • Quebec, Canada, G1V 4G5
        • Novartis Investigative Site
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Novartis Investigative Site
      • Edmonton, Alberta, Canada, T5H 3V9
        • Novartis Investigative Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 3C3
        • Novartis Investigative Site
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Novartis Investigative Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H1T 1C8
        • Novartis Investigative Site
  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36693
        • Novartis Investigative Site
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85054
        • Novartis Investigative Site
      • Tucson, Arizona, Forenede Stater, 85723-0001
        • Novartis Investigative Site
      • Tucson, Arizona, Forenede Stater, 85745
        • Novartis Investigative Site
    • California
      • Los Angeles, California, Forenede Stater, 90033
        • Novartis Investigative Site
      • Los Angeles, California, Forenede Stater, 90095
        • Novartis Investigative Site
      • San Diego, California, Forenede Stater, 92161
        • Novartis Investigative Site
      • Stockton, California, Forenede Stater, 95204
        • Novartis Investigative Site
      • Torrance, California, Forenede Stater, 90502
        • Novartis Investigative Site
    • Colorado
      • Boulder, Colorado, Forenede Stater, 80304
        • Novartis Investigative Site
    • Connecticut
      • Farmington, Connecticut, Forenede Stater, 06030-3100
        • Novartis Investigative Site
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010
        • Novartis Investigative Site
      • Washington, District of Columbia, Forenede Stater, 20037
        • Novartis Investigative Site
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610
        • Novartis Investigative Site
      • Hudson, Florida, Forenede Stater, 34667
        • Novartis Investigative Site
      • Miami, Florida, Forenede Stater, 33137-3732
        • Novartis Investigative Site
      • Port Charlotte, Florida, Forenede Stater, 33952
        • Novartis Investigative Site
      • Safety Harbor, Florida, Forenede Stater, 34695
        • Novartis Investigative Site
    • Georgia
      • Decatur, Georgia, Forenede Stater, 30033
        • Novartis Investigative Site
    • Indiana
      • Elkhart, Indiana, Forenede Stater, 46514
        • Novartis Investigative Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • Novartis Investigative Site
      • Louisville, Kentucky, Forenede Stater, 40202
        • Novartis Investigative Site
    • Louisiana
      • Covington, Louisiana, Forenede Stater, 70433
        • Novartis Investigative Site
    • Maryland
      • Columbia, Maryland, Forenede Stater, 21044
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater
        • Novartis Investigative Site
    • Michigan
      • Flint, Michigan, Forenede Stater, 48532
        • Novartis Investigative Site
      • Kalamazoo, Michigan, Forenede Stater, 49048
        • Novartis Investigative Site
      • Midland, Michigan, Forenede Stater, 48640
        • Novartis Investigative Site
      • Petoskey, Michigan, Forenede Stater, 49770
        • Novartis Investigative Site
      • Saginaw, Michigan, Forenede Stater, 48601
        • Novartis Investigative Site
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905-0001
        • Novartis Investigative Site
      • St. Paul, Minnesota, Forenede Stater, 55102
        • Novartis Investigative Site
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65212
        • Novartis Investigative Site
    • New Jersey
      • Ridgewood, New Jersey, Forenede Stater, 07450
        • Novartis Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131-5271
        • Novartis Investigative Site
    • New York
      • Buffalo, New York, Forenede Stater, 14215
        • Novartis Investigative Site
      • New York, New York, Forenede Stater, 10011
        • Novartis Investigative Site
      • Syracuse, New York, Forenede Stater, 13210-1640
        • Novartis Investigative Site
      • Williamsville, New York, Forenede Stater, 14221
        • Novartis Investigative Site
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27610
        • Novartis Investigative Site
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58122
        • Novartis Investigative Site
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44109-1998
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73109
        • Novartis Investigative Site
      • Tulsa, Oklahoma, Forenede Stater, 74104-4243
        • Novartis Investigative Site
    • Oregon
      • Bend, Oregon, Forenede Stater, 97701
        • Novartis Investigative Site
      • Hillsboro, Oregon, Forenede Stater, 97123
        • Novartis Investigative Site
    • Pennsylvania
      • Danville, Pennsylvania, Forenede Stater, 17822-2001
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Novartis Investigative Site
    • Tennessee
      • Johnson City, Tennessee, Forenede Stater, 37604
        • Novartis Investigative Site
      • Memphis, Tennessee, Forenede Stater, 38104
        • Novartis Investigative Site
      • Oak Ridge, Tennessee, Forenede Stater, 37830
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, Forenede Stater, 75226
        • Novartis Investigative Site
      • Katy, Texas, Forenede Stater, 77493
        • Novartis Investigative Site
      • San Antonio, Texas, Forenede Stater, 78229-3900
        • Novartis Investigative Site
  • Frankrig
      • Creteil, Frankrig, 94010
        • Novartis Investigative Site
      • Le Plessis Robinson, Frankrig, 92350
        • Novartis Investigative Site
      • Pessac Cedex, Frankrig, 33604
        • Novartis Investigative Site
      • Toulouse Cedex, Frankrig, 31059
        • Novartis Investigative Site
  • Italien
      • Novara, Italien, 28100
        • Novartis Investigative Site
    • AR
      • Arezzo, AR, Italien, 52100
        • Novartis Investigative Site
    • BG
      • Bergamo, BG, Italien, 24128
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italien, 20132
        • Novartis Investigative Site
      • Rozzano, MI, Italien, 20089
        • Novartis Investigative Site
      • Sesto San Giovanni, MI, Italien, 20099
        • Novartis Investigative Site
    • MS
      • Massa, MS, Italien, 54100
        • Novartis Investigative Site
    • PR
      • Parma, PR, Italien, 43100
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italien, 00185
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italien, 53100
        • Novartis Investigative Site
  • Polen
      • Bialystok, Polen, 15-276
        • Novartis Investigative Site
      • Kraków, Polen, 31-531
        • Novartis Investigative Site
      • Lódz, Polen, 90-549
        • Novartis Investigative Site
      • Warszawa, Polen, 04-628
        • Novartis Investigative Site
  • Spanien
      • Barcelona, Spanien, 08025
        • Novartis Investigative Site
      • Madrid, Spanien, 28046
        • Novartis Investigative Site
      • Madrid, Spanien, 28040
        • Novartis Investigative Site
    • Andalucia
      • Malaga, Andalucia, Spanien, 29010
        • Novartis Investigative Site
    • Asturias
      • Oviedo, Asturias, Spanien, 33006
        • Novartis Investigative Site
    • Cantabria
      • Santander, Cantabria, Spanien, 39008
        • Novartis Investigative Site
    • Cataluña
      • Barcelona, Cataluña, Spanien, 08035
        • Novartis Investigative Site
      • Barcelona, Cataluña, Spanien, 08003
        • Novartis Investigative Site
      • Hospitalet de Llobregat, Cataluña, Spanien, 08907
        • Novartis Investigative Site
    • Galicia
      • Santiago de Compostela, Galicia, Spanien, 15706
        • Novartis Investigative Site
      • Vigo, Galicia, Spanien, 36200
        • Novartis Investigative Site
    • Madrid
      • Majadanonda, Madrid, Spanien, 28220
        • Novartis Investigative Site
    • Pais Vasco
      • Galdakano, Pais Vasco, Spanien, 48960
        • Novartis Investigative Site
  • Tyskland
      • Coburg, Tyskland, 96450
        • Novartis Investigative Site
      • Essen, Tyskland, 45122
        • Novartis Investigative Site
      • Frankfurt, Tyskland, 60316
        • Novartis Investigative Site
      • Hamburg, Tyskland, 20246
        • Novartis Investigative Site
      • Hamburg, Tyskland, 20099
        • Novartis Investigative Site
      • Leipzig, Tyskland, 04289
        • Novartis Investigative Site
      • Ludwigshafen, Tyskland, 67063
        • Novartis Investigative Site
      • Muenchen, Tyskland, 81737
        • Novartis Investigative Site
      • Neuss, Tyskland, 41464
        • Novartis Investigative Site
  • Ungarn
      • Budapest, Ungarn, 1134
        • Novartis Investigative Site
      • Budapest, Ungarn, 1122
        • Novartis Investigative Site
      • Debrecen, Ungarn, 4032
        • Novartis Investigative Site
      • Szeged, Ungarn, 6720
        • Novartis Investigative Site
    • Baranya
      • Pecs, Baranya, Ungarn, 7621
        • 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

35 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with CAD who have blood pressure in the pre-hypertensive range defined as a msSBP ≥ 125 and ≤ 139mmHg and a msDBP < 90mmHg.
  • Patients with or without current treatment for hypertension
  • Angiographic evidence of coronary artery disease
  • At least 2 qualifying Cardiovascular risk factors at Visit 1

Exclusion Criteria:

  • Baseline IVUS determined unacceptable
  • Patients requiring treatment with disallowed study medications
  • Patients with clinically significant heart disease
  • Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left ventricular ejection fraction of < 25%

  • Patients requiring treatment with any 2 of the following classes of medication at Visit 1 or Visit 2:

    • Angiotensin converting enzyme inhibitors
    • Angiotensin receptor blockers
    • aldosterone receptor blockers or a direct renin inhibitor.
  • Other conditions 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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: 1
Medicin: Placebo
Placebo
Eksperimentel: 2
Aliskiren 300 mg
Medicin: Aliskiren
300 mg

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment
Tidsramme: Baseline, 104 weeks
Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases
Baseline, 104 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS
Tidsramme: Baseline, 104 weeks
Change from baseline in normalized total atheroma volume (TAV) (mm^3) for all matched slices of anatomically comparable segments of the target coronary artery were assess by IVUS after 104 weeks of treatment. calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases
Baseline, 104 weeks
Patients That Demonstrated Evidence of Atheroma Regression
Tidsramme: Baseline to endpoint (104 weeks)
Atheroma regression is defined as change from baseline to endpoint in PAV <0 .
Baseline to endpoint (104 weeks)
Number of Patients With Adverse Events, Serious Adverse Events, and Death
Tidsramme: 104 weeks
overall safety and tolerability of aliskiren 300 mg compared to placebo in patients with CAD and BP in the pre-hypertensive (high normal) range with or without treatment for hypertension following 104 weeks of treatment. Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity.
104 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

Samarbejdspartnere

The Cleveland Clinic

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. marts 2009

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først indsendt

26. februar 2009

Først indsendt, der opfyldte QC-kriterier

27. februar 2009

Først opslået (Skøn)

2. marts 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CSPP100A2366
  • 2008-006447-40

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 Koronararteriesygdom (CAD)

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner