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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 janeiro de 2014 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

589

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • 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
  • Eslováquia
      • Bratislava, Eslováquia, 821 07
        • Novartis Investigative Site
      • Martin, Eslováquia, 036 01
        • Novartis Investigative Site
      • Presov, Eslováquia, 080 01
        • Novartis Investigative Site
      • Sala, Eslováquia, 927 03
        • Novartis Investigative Site
      • Zvolen, Eslováquia, 960 01
        • Novartis Investigative Site
    • Slovak Republic
      • Kosice, Slovak Republic, Eslováquia, 040 11
        • Novartis Investigative Site
      • Svidnik, Slovak Republic, Eslováquia, 08901
        • Novartis Investigative Site
    • Slovak republic
      • Banská Bystrica, Slovak republic, Eslováquia, 97405
        • Novartis Investigative Site
      • Bratislava, Slovak republic, Eslováquia, 83299
        • Novartis Investigative Site
      • Kosice, Slovak republic, Eslováquia, 04001
        • Novartis Investigative Site
      • Nitra, Slovak republic, Eslováquia, 95201
        • Novartis Investigative Site
      • Rimavska Sobota, Slovak republic, Eslováquia, 97901
        • Novartis Investigative Site
      • Senec, Slovak republic, Eslováquia, 90301
        • Novartis Investigative Site
      • Snina, Slovak republic, Eslováquia, 09601
        • Novartis Investigative Site
      • Trnava, Slovak republic, Eslováquia, 91701
        • Novartis Investigative Site
  • Espanha
      • Madrid, Espanha, 28009
        • Novartis Investigative Site
    • Cataluña
      • Barcelona, Cataluña, Espanha, 08905
        • Novartis Investigative Site
      • Centelles, Cataluña, Espanha, 08540
        • Novartis Investigative Site
      • Corbera de Llobregat, Cataluña, Espanha, 08757
        • Novartis Investigative Site
      • Hostalets de Balenya, Cataluña, Espanha, 08550
        • Novartis Investigative Site
      • Vic, Cataluña, Espanha, 08500
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alzira, Comunidad Valenciana, Espanha, 46600
        • Novartis Investigative Site
      • Quart de Poblet, Comunidad Valenciana, Espanha, 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
  • Itália
    • IS
      • Pozzilli, IS, Itália, 86077
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Itália, 27100
        • Novartis Investigative Site
    • SS
      • Sassari, SS, Itália, 07100
        • Novartis Investigative Site
  • Porto Rico
      • Carolina, Porto Rico, 00983
        • Novartis Investigative Site
      • Cidra, Porto Rico, 00739
        • Novartis Investigative Site
      • Manati, Porto Rico, 00674
        • 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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

-

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Aliskiren: Fed
Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
Medicamento: Aliskiren
Aliskiren 300 mg once daily
Outros nomes:
  • Tekturna, rasilez
Experimental: Aliskiren: Fasting
Aliskiren 300 mg once daily taken after after an overnight fast
Medicamento: Aliskiren
Aliskiren 300 mg once daily
Outros nomes:
  • Tekturna, rasilez

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 8 weeks
8 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Novartis Pharmaceuticals

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de abril de 2012

Conclusão Primária (Real)

1 de novembro de 2012

Conclusão do estudo (Real)

1 de novembro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

2 de abril de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de abril de 2012

Primeira postagem (Estimativa)

4 de abril de 2012

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

22 de janeiro de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de janeiro de 2014

Última verificação

1 de janeiro de 2014

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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