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8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension

15. januar 2014 opdateret af: Novartis Pharmaceuticals

An 8-week Randomized, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Oral Aliskiren 300 mg Once Daily Under Light Meal Versus Fasted Condition in Patients With Hypertension

The purpose of this study is to evaluate the effect of food on aliskiren's efficacy, pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light meal versus fasted conditions.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

589

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Novartis Investigative Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
        • Novartis Investigative Site
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M9W 4L6
        • Novartis Investigative Site
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
        • Novartis Investigative Site
      • Sainte-Foy, Quebec, Canada, G1W 4R4
        • Novartis Investigative Site
  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90057
        • Novartis Investigative Site
      • Riverside, California, Forenede Stater, 92506
        • Novartis Investigative Site
      • Santa Monica, California, Forenede Stater, 90404
        • Novartis Investigative Site
      • Walnut Creek, California, Forenede Stater, 94598
        • Novartis Investigative Site
      • Westlake Village, California, Forenede Stater, 91361
        • Novartis Investigative Site
    • Florida
      • Coral Gables, Florida, Forenede Stater, 33134
        • Novartis Investigative Site
      • Miami, Florida, Forenede Stater, 33169
        • Novartis Investigative Site
      • South Miami, Florida, Forenede Stater, 33143
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60607
        • Novartis Investigative Site
      • Chicago, Illinois, Forenede Stater, 60610
        • Novartis Investigative Site
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47712
        • Novartis Investigative Site
    • Kansas
      • Topeka, Kansas, Forenede Stater, 66606
        • Novartis Investigative Site
    • Louisiana
      • Opelousas, Louisiana, Forenede Stater, 70570
        • Novartis Investigative Site
    • Minnesota
      • Chaska, Minnesota, Forenede Stater, 55318
        • Novartis Investigative Site
      • Edina, Minnesota, Forenede Stater, 55435
        • Novartis Investigative Site
      • St. Paul, Minnesota, Forenede Stater, 55114
        • Novartis Investigative Site
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39209
        • Novartis Investigative Site
      • Picayune, Mississippi, Forenede Stater, 39466
        • Novartis Investigative Site
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63141
        • Novartis Investigative Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28209
        • Novartis Investigative Site
      • Greensboro, North Carolina, Forenede Stater, 27401
        • Novartis Investigative Site
      • Greensboro, North Carolina, Forenede Stater, 27408
        • Novartis Investigative Site
      • Salisbury, North Carolina, Forenede Stater, 28144
        • Novartis Investigative Site
      • Shelby, North Carolina, Forenede Stater, 28152
        • Novartis Investigative Site
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45246
        • Novartis Investigative Site
      • Columbus, Ohio, Forenede Stater, 43213
        • Novartis Investigative Site
      • Lyndhurst, Ohio, Forenede Stater, 44124
        • Novartis Investigative Site
      • Marion, Ohio, Forenede Stater, 43302
        • Novartis Investigative Site
    • Oklahoma
      • Norman, Oklahoma, Forenede Stater, 73069
        • Novartis Investigative Site
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97404
        • Novartis Investigative Site
      • Oregon City, Oregon, Forenede Stater, 97045
        • Novartis Investigative Site
      • Portland, Oregon, Forenede Stater, 97239
        • Novartis Investigative Site
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37920
        • Novartis Investigative Site
    • Texas
      • Beaumont, Texas, Forenede Stater, 77702
        • Novartis Investigative Site
      • Houston, Texas, Forenede Stater, 77081
        • Novartis Investigative Site
      • Lake Jackson, Texas, Forenede Stater, 77566
        • Novartis Investigative Site
      • Pasadena, Texas, Forenede Stater, 77504
        • Novartis Investigative Site
    • Utah
      • Centerville, Utah, Forenede Stater, 84104
        • Novartis Investigative Site
    • Virginia
      • Arlington, Virginia, Forenede Stater, 22203
        • Novartis Investigative Site
      • Ettrick, Virginia, Forenede Stater, 23803
        • Novartis Investigative Site
      • Midlothian, Virginia, Forenede Stater, 23114
        • Novartis Investigative Site
    • Washington
      • Port Orchard, Washington, Forenede Stater, 98366
        • Novartis Investigative Site
  • Italien
    • IS
      • Pozzilli, IS, Italien, 86077
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italien, 27100
        • Novartis Investigative Site
    • SS
      • Sassari, SS, Italien, 07100
        • Novartis Investigative Site
  • Puerto Rico
      • Carolina, Puerto Rico, 00983
        • Novartis Investigative Site
      • Cidra, Puerto Rico, 00739
        • Novartis Investigative Site
      • Manati, Puerto Rico, 00674
        • Novartis Investigative Site
  • Slovakiet
      • Bratislava, Slovakiet, 821 07
        • Novartis Investigative Site
      • Martin, Slovakiet, 036 01
        • Novartis Investigative Site
      • Presov, Slovakiet, 080 01
        • Novartis Investigative Site
      • Sala, Slovakiet, 927 03
        • Novartis Investigative Site
      • Zvolen, Slovakiet, 960 01
        • Novartis Investigative Site
    • Slovak Republic
      • Kosice, Slovak Republic, Slovakiet, 040 11
        • Novartis Investigative Site
      • Svidnik, Slovak Republic, Slovakiet, 08901
        • Novartis Investigative Site
    • Slovak republic
      • Banská Bystrica, Slovak republic, Slovakiet, 97405
        • Novartis Investigative Site
      • Bratislava, Slovak republic, Slovakiet, 83299
        • Novartis Investigative Site
      • Kosice, Slovak republic, Slovakiet, 04001
        • Novartis Investigative Site
      • Nitra, Slovak republic, Slovakiet, 95201
        • Novartis Investigative Site
      • Rimavska Sobota, Slovak republic, Slovakiet, 97901
        • Novartis Investigative Site
      • Senec, Slovak republic, Slovakiet, 90301
        • Novartis Investigative Site
      • Snina, Slovak republic, Slovakiet, 09601
        • Novartis Investigative Site
      • Trnava, Slovak republic, Slovakiet, 91701
        • Novartis Investigative Site
  • Spanien
      • Madrid, Spanien, 28009
        • Novartis Investigative Site
    • Cataluña
      • Barcelona, Cataluña, Spanien, 08905
        • Novartis Investigative Site
      • Centelles, Cataluña, Spanien, 08540
        • Novartis Investigative Site
      • Corbera de Llobregat, Cataluña, Spanien, 08757
        • Novartis Investigative Site
      • Hostalets de Balenya, Cataluña, Spanien, 08550
        • Novartis Investigative Site
      • Vic, Cataluña, Spanien, 08500
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alzira, Comunidad Valenciana, Spanien, 46600
        • Novartis Investigative Site
      • Quart de Poblet, Comunidad Valenciana, Spanien, 46930
        • Novartis Investigative Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 114
        • Novartis Investigative Site
    • Taiwan, ROC
      • Taipei, Taiwan, ROC, Taiwan, 112
        • 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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy).
  • Patients with an office BP ≥ 140/90 mmHg and < 180/110mmHg at the randomization visit and the preceding visit
  • Patients must have an absolute difference of ≤ 10 mmHg in both their msSBP and their msDBP between the randomization visit and the preceding visit

Exclusion Criteria:

  • Malignant hypertension or severe hypertension (grade 3 of WHO classification; msSBP ≥180 mmHg or msDBP ≥110 mmHg)
  • History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease (PKD).
  • Type 1 or Type 2 diabetes mellitus with a fasting glycosylated hemoglobin (HbA1c) > 8%
  • Evidence of renal impairment as determined by one of the following: serum creatinine >1.5 x ULN or eGFR < 30 ml/min/1.73m2 at Visit 1, a history of dialysis, or a history of nephrotic syndrome

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Aliskiren: Fed
Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
Medicin: Aliskiren
Aliskiren 300 mg once daily
Andre navne:
  • Tekturna, rasilez
Eksperimentel: Aliskiren: Fasting
Aliskiren 300 mg once daily taken after after an overnight fast
Medicin: Aliskiren
Aliskiren 300 mg once daily
Andre navne:
  • Tekturna, rasilez

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
Tidsramme: Baseline, week 8
24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maSBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.
Baseline, week 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
Tidsramme: Baseline, week 8
24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maDBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.
Baseline, week 8
Percentage of Patients Achieving Blood Pressure Control
Tidsramme: 8 weeks
Patients achieving blood pressure control were patients who, at week 8, had a mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) < 140/90 mmHg
8 weeks
Change From Baseline (Visit 3) to End of Study (8 Weeks) in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
Tidsramme: Baseline, Week 8
Sitting blood pressure (BP) was measured at trough (approximately 24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the BP was checked in both arms and the arm with higher systolic BP (SBP) was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures (msSBP and msDBP) were measured four times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 2 minute intervals and the mean of all four sitting blood pressure measurements was used as the average sitting office blood pressure for that visit. The analysis of covariance (ANCOVA) model used treatment, region as factors, and baseline as covariate.
Baseline, Week 8
Percentage of Patients Achieving a Successful Response in Systolic Blood Pressure Reduction
Tidsramme: Baseline, Week 8
Successful response in systolic blood pressure reduction at end of 8-week treatment was defined as msSBP <140 mmHg or a reduction in msSBP ≥ 20 mmHg from baseline.
Baseline, Week 8
Pharmacokinetic (PK) of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration in Fasted vs. Fed
Tidsramme: Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)
Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.
Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)
Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) in Fasted vs. Fed
Tidsramme: Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)
Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.
Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)
Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration in Fasted vs. Fed
Tidsramme: Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)
Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.
Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)
Change From Baseline to Week 8 in Plasma Renin Activity (PRA)
Tidsramme: Baseline, Week 8
Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin activity (PRA) . Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8).The difference between baseline and week 8 was calculated.
Baseline, Week 8
Change From Baseline to Week 8 in Plasma Renin Concentration (PRC)
Tidsramme: Baseline, Week 8
Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin concentration (PRC). Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8). The difference between baseline and week 8 was calculated.
Baseline, Week 8
Number of Patients With Adverse Events, Serious Adverse Events and Death
Tidsramme: 8 weeks
8 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

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 2012

Primær færdiggørelse (Faktiske)

1. november 2012

Studieafslutning (Faktiske)

1. november 2012

Datoer for studieregistrering

Først indsendt

2. april 2012

Først indsendt, der opfyldte QC-kriterier

2. april 2012

Først opslået (Skøn)

4. april 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. januar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CSPP100A2413
  • 2011-005297-36 (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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Sponsorer og samarbejdspartnere

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CROs in Georgia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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