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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 de enero de 2014 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

589

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

-

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Aliskiren: Fed
Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
Droga: Aliskiren
Aliskiren 300 mg once daily
Otros nombres:
  • Tekturna, rasilez
Experimental: Aliskiren: Fasting
Aliskiren 300 mg once daily taken after after an overnight fast
Droga: Aliskiren
Aliskiren 300 mg once daily
Otros nombres:
  • Tekturna, rasilez

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 8 weeks
8 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novartis Pharmaceuticals

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de abril de 2012

Finalización primaria (Actual)

1 de noviembre de 2012

Finalización del estudio (Actual)

1 de noviembre de 2012

Fechas de registro del estudio

Enviado por primera vez

2 de abril de 2012

Primero enviado que cumplió con los criterios de control de calidad

2 de abril de 2012

Publicado por primera vez (Estimar)

4 de abril de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

22 de enero de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

15 de enero de 2014

Última verificación

1 de enero de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CSPP100A2413
  • 2011-005297-36 (Número EudraCT)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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