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An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age

8. februar 2016 opdateret af: Novartis Pharmaceuticals

A Multicenter, Double-blind, Randomized, 52-week, Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age

The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term safety, tolerability and efficacy profile of aliskiren compared to the active comparator enalapril in children, 6 - 17 years old with hypertension (msSBP ≥ 95th percentile for age, gender and height, at baseline in study CSPP100A2365). Patients will be randomized to receive either aliskiren or enalapril. Weight-group based doses of aliskiren or enalapril will be administered once daily and children will receive study medication in a double-blind manner. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in pediatric patients 6-17 years of age (age at baseline in Study CSPP100A2365).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

208

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294-0006
        • Novartis Investigative Site
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72202
        • Novartis Investigative Site
    • California
      • Los Angeles, California, Forenede Stater, 90048
        • Novartis Investigative Site
    • Georgia
      • Dalton, Georgia, Forenede Stater, 30721
        • Novartis Investigative Site
    • Idaho
      • Lewiston, Idaho, Forenede Stater, 83501
        • Novartis Investigative Site
    • Illinois
      • Park Ridge, Illinois, Forenede Stater, 60068
        • Novartis Investigative Site
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • Novartis Investigative Site
    • Mississippi
      • Hattiesburg, Mississippi, Forenede Stater, 39401
        • Novartis Investigative Site
      • Jackson, Mississippi, Forenede Stater, 39209
        • Novartis Investigative Site
    • New York
      • New York, New York, Forenede Stater, 10016
        • Novartis Investigative Site
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43205
        • Novartis Investigative Site
      • Toledo, Ohio, Forenede Stater, 43606
        • Novartis Investigative Site
    • Oregon
      • Portland, Oregon, Forenede Stater, 97225
        • Novartis Investigative Site
      • Portland, Oregon, Forenede Stater, 07227
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Novartis Investigative Site
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Novartis Investigative Site
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25304
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala, 01010
        • Novartis Investigative Site
  • Kalkun
      • Ankara, Kalkun, 06100
        • Novartis Investigative Site
      • Ankara, Kalkun, 06500
        • Novartis Investigative Site
      • Ankara, Kalkun, 06490
        • Novartis Investigative Site
  • Polen
      • Warszawa, Polen, 04-154
        • Novartis Investigative Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00907
        • Novartis Investigative Site
  • Slovakiet
      • Bratislava, Slovakiet, 85107
        • Novartis Investigative Site
      • Bratislava, Slovakiet, 84103
        • Novartis Investigative Site
      • Martin, Slovakiet, 03601
        • Novartis Investigative Site
      • Myjava, Slovakiet, 90701
        • Novartis Investigative Site
      • Presov, Slovakiet, 08001
        • Novartis Investigative Site
      • Trnava, Slovakiet, 91701
        • Novartis Investigative Site
  • Ungarn
      • Budapest, Ungarn, 1083
        • Novartis Investigative Site
      • Budapest, Ungarn, 1131
        • Novartis Investigative Site
      • Debrecen, Ungarn, 4032
        • Novartis Investigative Site
      • Miskolc, Ungarn, 3529
        • Novartis Investigative Site
      • Nyiregyhaza, Ungarn, 4400
        • Novartis Investigative Site
      • Szeged, Ungarn, 6725
        • Novartis Investigative Site
      • Veszprem, Ungarn, H-8200
        • 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

6 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • msSBP (mean of 3 systolic blood pressure measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization), in study CSPP100A2365
  • Must be ≥ 20 kg and ≤ 150 kg at Visit 2 (randomization), in study CSPP100A2365
  • Must be able to swallow minitablets (2mm in diameter) administered in soft food
  • Successful completion of Phase 1 (dose response phase) and at least 1 week of Phase 2 (placebo withdrawal phase) of the CSPP100A2365 protocol, with no serious drug-related adverse event(s).

Exclusion Criteria:

  • Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
  • Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or obstructive valvular disease
  • msSBP ≥ 25% above the 95th percentile
  • Second or third degree heart block without a pacemaker
  • AST/SGOT or ALT/SGPT >3 times the upper limit of the reference range
  • Total bilirubin > 2 times the upper limit of the reference range
  • Creatinine clearance < 30 mL/min/1.73m² (calculated using Modified Schwartz formula to estimate glomerular filtration rate [GFR]), based on the serum creatinine concentration obtained at the screening visit)
  • WBC count < 3000/mm³
  • Platelet count < 100,000/mm³
  • Serum potassium > 5.2 mEq/L
  • 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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Aliskiren
Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
Medicin: Aliskiren

Low weight patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg

Mid weight patients: Starting dose 75 mg with optional titration to 150 and then 300 mg

High weight patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
Aktiv komparator: Enalapril
Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
Medicin: Enalapril

Low weight patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg

Mid weight patients: Starting dose 5 mg with optional titration to 10 and then 20 mg

High weight patients: Starting dose 10 mg with optional titration to 20 and then 40 mg

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study
Tidsramme: Baseline - end of study (Week 52 or Last observation carried forward (LOCF)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Baseline - end of study (Week 52 or Last observation carried forward (LOCF)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
Tidsramme: Baseline - end of study (Week 52 or Last observation carried forward (LOCF)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.
Baseline - end of study (Week 52 or Last observation carried forward (LOCF)
Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study
Tidsramme: Baseline to end of study (Week 52 or LOCF)
MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3*(SBP--DBP).
Baseline to end of study (Week 52 or LOCF)

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. august 2010

Primær færdiggørelse (Faktiske)

1. august 2015

Studieafslutning (Faktiske)

1. august 2015

Datoer for studieregistrering

Først indsendt

23. juni 2010

Først indsendt, der opfyldte QC-kriterier

25. juni 2010

Først opslået (Skøn)

28. juni 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. februar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CSPP100A2365E1
  • 2009-017029-20 (EudraCT nummer)

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 .

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