- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01570686
8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension
15 janvier 2014 mis à jour par: 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.
Aperçu de l'étude
Type d'étude
Interventionnel
Inscription (Réel)
589
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New Brunswick
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Moncton, New Brunswick, Canada, E1G 1A7
- Novartis Investigative Site
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1A 3R5
- Novartis Investigative Site
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Ontario
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Brampton, Ontario, Canada, L6T 0G1
- Novartis Investigative Site
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Toronto, Ontario, Canada, M9W 4L6
- Novartis Investigative Site
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Quebec
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Mirabel, Quebec, Canada, J7J 2K8
- Novartis Investigative Site
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Sainte-Foy, Quebec, Canada, G1W 4R4
- Novartis Investigative Site
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Madrid, Espagne, 28009
- Novartis Investigative Site
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Cataluña
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Barcelona, Cataluña, Espagne, 08905
- Novartis Investigative Site
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Centelles, Cataluña, Espagne, 08540
- Novartis Investigative Site
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Corbera de Llobregat, Cataluña, Espagne, 08757
- Novartis Investigative Site
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Hostalets de Balenya, Cataluña, Espagne, 08550
- Novartis Investigative Site
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Vic, Cataluña, Espagne, 08500
- Novartis Investigative Site
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Comunidad Valenciana
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Alzira, Comunidad Valenciana, Espagne, 46600
- Novartis Investigative Site
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Quart de Poblet, Comunidad Valenciana, Espagne, 46930
- Novartis Investigative Site
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IS
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Pozzilli, IS, Italie, 86077
- Novartis Investigative Site
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PV
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Pavia, PV, Italie, 27100
- Novartis Investigative Site
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SS
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Sassari, SS, Italie, 07100
- Novartis Investigative Site
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Carolina, Porto Rico, 00983
- Novartis Investigative Site
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Cidra, Porto Rico, 00739
- Novartis Investigative Site
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Manati, Porto Rico, 00674
- Novartis Investigative Site
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Bratislava, Slovaquie, 821 07
- Novartis Investigative Site
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Martin, Slovaquie, 036 01
- Novartis Investigative Site
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Presov, Slovaquie, 080 01
- Novartis Investigative Site
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Sala, Slovaquie, 927 03
- Novartis Investigative Site
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Zvolen, Slovaquie, 960 01
- Novartis Investigative Site
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Slovak Republic
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Kosice, Slovak Republic, Slovaquie, 040 11
- Novartis Investigative Site
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Svidnik, Slovak Republic, Slovaquie, 08901
- Novartis Investigative Site
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Slovak republic
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Banská Bystrica, Slovak republic, Slovaquie, 97405
- Novartis Investigative Site
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Bratislava, Slovak republic, Slovaquie, 83299
- Novartis Investigative Site
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Kosice, Slovak republic, Slovaquie, 04001
- Novartis Investigative Site
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Nitra, Slovak republic, Slovaquie, 95201
- Novartis Investigative Site
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Rimavska Sobota, Slovak republic, Slovaquie, 97901
- Novartis Investigative Site
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Senec, Slovak republic, Slovaquie, 90301
- Novartis Investigative Site
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Snina, Slovak republic, Slovaquie, 09601
- Novartis Investigative Site
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Trnava, Slovak republic, Slovaquie, 91701
- Novartis Investigative Site
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Changhua, Taïwan, 500
- Novartis Investigative Site
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Taichung, Taïwan, 40447
- Novartis Investigative Site
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Taipei, Taïwan, 10002
- Novartis Investigative Site
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Taipei, Taïwan, 114
- Novartis Investigative Site
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Taiwan, ROC
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Taipei, Taiwan, ROC, Taïwan, 112
- Novartis Investigative Site
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California
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Los Angeles, California, États-Unis, 90057
- Novartis Investigative Site
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Riverside, California, États-Unis, 92506
- Novartis Investigative Site
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Santa Monica, California, États-Unis, 90404
- Novartis Investigative Site
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Walnut Creek, California, États-Unis, 94598
- Novartis Investigative Site
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Westlake Village, California, États-Unis, 91361
- Novartis Investigative Site
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Florida
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Coral Gables, Florida, États-Unis, 33134
- Novartis Investigative Site
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Miami, Florida, États-Unis, 33169
- Novartis Investigative Site
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South Miami, Florida, États-Unis, 33143
- Novartis Investigative Site
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Illinois
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Chicago, Illinois, États-Unis, 60607
- Novartis Investigative Site
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Chicago, Illinois, États-Unis, 60610
- Novartis Investigative Site
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Indiana
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Evansville, Indiana, États-Unis, 47712
- Novartis Investigative Site
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Kansas
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Topeka, Kansas, États-Unis, 66606
- Novartis Investigative Site
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Louisiana
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Opelousas, Louisiana, États-Unis, 70570
- Novartis Investigative Site
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Minnesota
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Chaska, Minnesota, États-Unis, 55318
- Novartis Investigative Site
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Edina, Minnesota, États-Unis, 55435
- Novartis Investigative Site
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St. Paul, Minnesota, États-Unis, 55114
- Novartis Investigative Site
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Mississippi
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Jackson, Mississippi, États-Unis, 39209
- Novartis Investigative Site
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Picayune, Mississippi, États-Unis, 39466
- Novartis Investigative Site
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Missouri
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St. Louis, Missouri, États-Unis, 63141
- Novartis Investigative Site
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North Carolina
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Charlotte, North Carolina, États-Unis, 28209
- Novartis Investigative Site
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Greensboro, North Carolina, États-Unis, 27401
- Novartis Investigative Site
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Greensboro, North Carolina, États-Unis, 27408
- Novartis Investigative Site
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Salisbury, North Carolina, États-Unis, 28144
- Novartis Investigative Site
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Shelby, North Carolina, États-Unis, 28152
- Novartis Investigative Site
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Winston-Salem, North Carolina, États-Unis, 27103
- Novartis Investigative Site
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Ohio
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Cincinnati, Ohio, États-Unis, 45246
- Novartis Investigative Site
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Columbus, Ohio, États-Unis, 43213
- Novartis Investigative Site
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Lyndhurst, Ohio, États-Unis, 44124
- Novartis Investigative Site
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Marion, Ohio, États-Unis, 43302
- Novartis Investigative Site
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Oklahoma
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Norman, Oklahoma, États-Unis, 73069
- Novartis Investigative Site
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Oregon
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Eugene, Oregon, États-Unis, 97404
- Novartis Investigative Site
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Oregon City, Oregon, États-Unis, 97045
- Novartis Investigative Site
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Portland, Oregon, États-Unis, 97239
- Novartis Investigative Site
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Tennessee
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Knoxville, Tennessee, États-Unis, 37920
- Novartis Investigative Site
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Texas
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Beaumont, Texas, États-Unis, 77702
- Novartis Investigative Site
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Houston, Texas, États-Unis, 77081
- Novartis Investigative Site
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Lake Jackson, Texas, États-Unis, 77566
- Novartis Investigative Site
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Pasadena, Texas, États-Unis, 77504
- Novartis Investigative Site
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Utah
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Centerville, Utah, États-Unis, 84104
- Novartis Investigative Site
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Virginia
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Arlington, Virginia, États-Unis, 22203
- Novartis Investigative Site
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Ettrick, Virginia, États-Unis, 23803
- Novartis Investigative Site
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Midlothian, Virginia, États-Unis, 23114
- Novartis Investigative Site
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Washington
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Port Orchard, Washington, États-Unis, 98366
- Novartis Investigative Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
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Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Aliskiren: Fed
Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
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Aliskiren 300 mg once daily
Autres noms:
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Expérimental: Aliskiren: Fasting
Aliskiren 300 mg once daily taken after after an overnight fast
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Aliskiren 300 mg once daily
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
Délai: Baseline, week 8
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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.
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Baseline, week 8
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
Délai: Baseline, week 8
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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.
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Baseline, week 8
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Percentage of Patients Achieving Blood Pressure Control
Délai: 8 weeks
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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
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8 weeks
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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)
Délai: Baseline, Week 8
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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.
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Baseline, Week 8
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Percentage of Patients Achieving a Successful Response in Systolic Blood Pressure Reduction
Délai: Baseline, Week 8
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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.
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Baseline, Week 8
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Pharmacokinetic (PK) of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration in Fasted vs. Fed
Délai: 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)
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Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.
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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)
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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
Délai: 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)
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Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.
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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)
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Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration in Fasted vs. Fed
Délai: 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)
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Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.
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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)
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Change From Baseline to Week 8 in Plasma Renin Activity (PRA)
Délai: Baseline, Week 8
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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.
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Baseline, Week 8
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Change From Baseline to Week 8 in Plasma Renin Concentration (PRC)
Délai: Baseline, Week 8
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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.
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Baseline, Week 8
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Number of Patients With Adverse Events, Serious Adverse Events and Death
Délai: 8 weeks
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8 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2012
Achèvement primaire (Réel)
1 novembre 2012
Achèvement de l'étude (Réel)
1 novembre 2012
Dates d'inscription aux études
Première soumission
2 avril 2012
Première soumission répondant aux critères de contrôle qualité
2 avril 2012
Première publication (Estimation)
4 avril 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
22 janvier 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 janvier 2014
Dernière vérification
1 janvier 2014
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CSPP100A2413
- 2011-005297-36 (Numéro EudraCT)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Hypertension
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National Taiwan University Hospital Hsin-Chu BranchRecrutementHypertension Essentielle | Hypertension, masquéTaïwan
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University of Alabama at BirminghamTroy UniversityComplétéHypertension | Hypertension, résistante à la thérapie conventionnelle | Hypertension non contrôlée | Hypertension, blouse blancheÉtats-Unis
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Vanderbilt University Medical CenterJohns Hopkins UniversityComplétéHypertension artérielle pulmonaire | Hypertension artérielle pulmonaire idiopathique | Hypertension artérielle pulmonaire associée | Hypertension artérielle pulmonaire héréditaireÉtats-Unis
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Amsterdam UMC, location VUmcZonMw: The Netherlands Organisation for Health Research and DevelopmentInconnue
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Centre Chirurgical Marie LannelongueInconnueHypertension pulmonaire thromboembolique chronique et hypertension artérielle pulmonaireFrance
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Assistance Publique - Hôpitaux de ParisActif, ne recrute pasHypertension portale non cirrhotique intrahépatiqueFrance
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AstraZenecaComplétéHypertension artérielle (hypertension).
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University of Kansas Medical CenterRecrutementHypertension artérielle pulmonaire | Hypertension pulmonaire | Hypertension pulmonaire thromboembolique chronique | Hypertension pulmonaire due à une cardiopathie gauche | Hypertension pulmonaire, primaire, 4 | Hypertension pulmonaire, primaire, 2 | Hypertension pulmonaire, primaire, 3 | Hypertension... et d'autres conditionsÉtats-Unis
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Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldComplétéHypertension artérielle pulmonaire idiopathique | Hypertension pulmonaire thromboembolique chroniqueRoyaume-Uni
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BayerComplété
Essais cliniques sur Aliskiren
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NovartisComplétéL'hypertension artérielle essentielleAllemagne, Espagne, États-Unis
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NovartisComplété
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Novartis PharmaceuticalsComplété
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NovartisComplété
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NovartisComplété
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Christiana Care Health ServicesComplété
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Mayo ClinicRetiréNéphropathie membraneuse idiopathiqueÉtats-Unis
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NovartisComplété
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Taipei Veterans General Hospital, TaiwanNational Taiwan University HospitalInconnueInsuffisance cardiaqueTaïwan