- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00942994
Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension (ASCENT)
16. maj 2011 opdateret af: Novartis
An 8-week Multicenter, Randomized, Double-blind, Active Controlled, Parallel Group, Forced Titration Study to Evaluate the Efficacy and Safety of Aliskiren/Amlodipine/HCTZ Compared to Aliskiren/Amlodipine in US Minority Patients With Stage 2 Hypertension
The purpose of the study is to compare the combination of aliskiren, amlodipine and Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in minority Stage 2 hypertensive patients.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
412
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72201
- K and S Research Services
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Florida
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South Miami, Florida, Forenede Stater, 33143
- Well Pharma Medical Research
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Massachusetts
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Mattapan, Massachusetts, Forenede Stater, 02126
- Hyde Park Health Associates
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Virginia
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Manassas, Virginia, Forenede Stater, 20110
- Manassas Clinical Research Center
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Washington
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Seattle, Washington, Forenede Stater, 98133
- Scriber Kidney Center
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients who are newly diagnosed or have a history of hypertension, who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
- Men or women 18 years and older of minority background; self-identified.
- Patients with stage 2 hypertension defined as MSSBP ≥160 mmHg and <200 mmHg at Visit 5 (randomization).
Exclusion Criteria:
- Patients with MSDBP ≥110 mmHg and/or MSSBP ≥200 mmHg as measured by office cuff at any visit.
- Patients on 4 or more antihypertensive medications.
- Patients with uncontrolled hypertension (MSSBP >180 mmHg) taking more than 1 antihypertensive medication at Visit 1.
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: Triple Therapy (Aliskiren/Amlodipine/HCTZ)
At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg.
At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5
mg.
At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg.
At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
|
Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg) HCTZ capsule (12.5 mg, 25mg) |
Aktiv komparator: Dual Therapy (Aliskiren/Amlodipine)
At week 0 patients were randomized to amlodipine 5 mg.
At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg.
At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg.
At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
|
Amlodipine capsule (5 mg) Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg) |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
Tidsramme: Baseline and week 8
|
To evaluate change from baseline in MSSBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.
|
Baseline and week 8
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
Tidsramme: Baseline and week 8
|
To evaluate change from baseline in MSDBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.
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Baseline and week 8
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Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks
Tidsramme: 8 weeks
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To evaluate the cumulative percentage of patients achieving Blood Pressure control (defined as patients achieving an MSSBP <140 mmHg and MSDBP <90 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.
Cumulative refers to achieving BP control before or at the corresponding visit.
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8 weeks
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Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.
Tidsramme: 8 weeks
|
To compare the cumulative percentage of responders (defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.
Cumulative refers to achieving a response before or at the corresponding visit.
|
8 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4
Tidsramme: Baseline, Week 2 and Week 4
|
Primary objective at additional timepoint.
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Baseline, Week 2 and Week 4
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Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4
Tidsramme: Baseline, Week 2 and Week 4
|
Secondary objective at additional timepoint.
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Baseline, Week 2 and Week 4
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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
- Ferdinand KC, Weitzman R, Israel M, Lee J, Purkayastha D, Jaimes EA. Efficacy and safety of aliskiren-based dual and triple combination therapies in US minority patients with stage 2 hypertension. J Am Soc Hypertens. 2011 Mar-Apr;5(2):102-13. doi: 10.1016/j.jash.2011.01.006.
- Ferdinand KC, Weitzman R, Purkayastha D, Sridharan K, Jaimes EA. Aliskiren-based dual- and triple-combination therapies in high-risk US minority patients with stage 2 hypertension. J Am Soc Hypertens. 2012 May-Jun;6(3):219-27. doi: 10.1016/j.jash.2011.12.002. Epub 2012 Feb 3.
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. juni 2009
Primær færdiggørelse (Faktiske)
1. marts 2010
Datoer for studieregistrering
Først indsendt
19. juli 2009
Først indsendt, der opfyldte QC-kriterier
20. juli 2009
Først opslået (Skøn)
21. juli 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. juni 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. maj 2011
Sidst verificeret
1. maj 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Forhøjet blodtryk
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antihypertensive midler
- Vasodilatorer
- Natriuretiske midler
- Membrantransportmodulatorer
- Diuretika
- Calciumregulerende hormoner og midler
- Calciumkanalblokkere
- Natriumchlorid Symporter-hæmmere
- Amlodipin
- Hydrochlorthiazid
Andre undersøgelses-id-numre
- CSPA100AUS02
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 Forhøjet blodtryk
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BayerAfsluttet
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National Taiwan University Hospital Hsin-Chu BranchRekrutteringHypertension, essentiel | Hypertension, maskeretTaiwan
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University of Kansas Medical CenterRekrutteringPulmonal arteriel hypertension | Pulmonal hypertension | Kronisk tromboembolisk pulmonal hypertension | Pulmonal hypertension på grund af venstre hjertesygdom | Pulmonal hypertension, primær, 4 | Pulmonal hypertension, primær, 2 | Pulmonal hypertension, primær, 3 | Pulmonal hypertension, primær | Pulmonal...Forenede Stater
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Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldAfsluttetIdiopatisk pulmonal arteriel hypertension | Kronisk tromboembolisk pulmonal hypertensionDet Forenede Kongerige
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University of South FloridaTrukket tilbagePulmonal arteriel hypertension | Familiær primær pulmonal hypertension | Idiopatisk pulmonal arteriel hypertension | Primær pulmonal hypertensionForenede Stater
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Centre Chirurgical Marie LannelongueUkendtKronisk trombo-embolisk pulmonal hypertension og pulmonal arteriel hypertensionFrankrig
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Heidelberg UniversityMerck Sharp & Dohme LLCRekrutteringKronisk tromboembolisk pulmonal hypertension | Primær pulmonal arteriel hypertensionTyskland
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Papworth Hospital NHS Foundation TrustMerck Sharp & Dohme LLCAfsluttet
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Vanderbilt University Medical CenterJohns Hopkins UniversityAfsluttetPulmonal arteriel hypertension | Idiopatisk pulmonal arteriel hypertension | Associeret pulmonal arteriel hypertension | Arvelig pulmonal arteriel hypertensionForenede Stater
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University of Alabama at BirminghamTroy UniversityAfsluttetForhøjet blodtryk | Hypertension, resistent over for konventionel terapi | Ukontrolleret hypertension | Hypertension, hvid pelsForenede Stater
Kliniske forsøg med Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)
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NovartisAfsluttet
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NovartisAfsluttet
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NovartisAfsluttetTrin 2 systolisk hypertensionForenede Stater
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NovartisAfsluttet
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NovartisAfsluttet
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Novartis PharmaceuticalsAfsluttet
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Novartis PharmaceuticalsAfsluttetKardiovaskulære begivenhederColombia, Indien, Sydafrika, Canada, Spanien, Ungarn, Forenede Stater, Tyskland, Irland, Argentina, Filippinerne, Brasilien, Sverige, Malaysia, Chile, Israel, Tjekkiet, Holland
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NovartisAfsluttetForhøjet blodtrykForenede Stater
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Novartis PharmaceuticalsBaker Heart and Diabetes InstituteAfsluttetForhøjet blodtrykForenede Stater, Australien
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Torrent Pharmaceuticals LimitedAfsluttet