- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02176499
Natriuretic Effect of Telmisartan Versus Placebo in Patients With Mild-to-Moderate Hypertension
7 de julho de 2014 atualizado por: Boehringer Ingelheim
Natriuretic Effect of Telmisartan Versus Placebo in Patients With Mild-to-Moderate Hypertension On a Controlled Sodium Diet (100 mmol/Day)
Study to compare the natriuretic effect of telmisartan to placebo in mild-to-moderate hypertensive patients on a controlled sodium diet as well as to explore the effects of telmisartan on norepinephrine, plasma renin activity (PRA), plasma aldosterone, urine potassium, creatinin, chloride, bicarbonate and uric acid excretion.
Additionally it was assessed whether the natriuretic effect disappears after treatment when telmisartan is stopped.
The effects of telmisartan on seated clinic blood pressure and the relationship between urine sodium loss and decrease in ambulatory blood pressure after the first dose were assessed descriptively.
Assessment of safety was also considered.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
26
Estágio
- Fase 3
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 a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Mild-to-moderate hypertension as defined by a morning mean diastolic blood pressure from ≥ 90 and ≤ 115 mmHg and a mean systolic blood pressure ≤ 200 mmHg after five minutes in the seated position at the end of three weeks of placebo run-in treatment
- Male or female patients between 18 and 65 years of age, inclusive. Patients 60 to 65 years of age must have a screening 24-hour urine creatinine clearance rate of ≥ 1 mL/sec
- Ability to provide written informed consent
Exclusion Criteria:
- Pre-menopausal women (last menstruation ≤ one year to start of screening)
Post-menopausal women (last menstruation > one year from start of screening or have had a hysterectomy and oophorectomy)
- Who have < three months of stable estrogen replacement therapy at screening
- Who will be on progesterone therapy at any time during the trial
- Known or suspected secondary hypertension
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than two times the upper limit of reference range
- Serum creatinine greater than 2.3 mg/dL
- Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant
- NYHA (New York Heart Association) functional class CHF (chronic heart failure) III-IV
- Unstable angina, myocardial infarction or cardiac surgery within the preceding three months
- Stroke within the preceding six months
- PTCA (percutaneous transluminal coronary angioplasty) within the preceding three months
- History of angioedema
- Sustained ventricular tachycardia, atrial fibrillation, or other clinically relevant cardiac arrhythmias as determined by the clinical Investigator
- Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve
- Administration of digoxin or other digitalis-type drugs
- Patients with insulin-dependent and non-insulin-dependent diabetes mellitus
- History of drug or alcohol dependency
- Use of antihypertensive agents such as diuretics, ACE inhibitors, angiotensin II antagonists, α-blockers, β-blockers, calcium channel antagonists, direct vasodilators at any time during the trial
- Administration of other non-antihypertensive medications known to affect blood pressure (e.g., oral corticosteroids, MAO (monoamine oxidase) inhibitors, nitrates) at any time during the trial
- Chronic administration of high doses of NSAIDS and aspirin (e.g., ibuprofen for rheumatoid arthritis and osteoarthritis in total daily dose in excess of 1600 mg, aspirin in excess of 2 Gm per day)
- Chronic use of salt substitutes containing potassium chloride; potassium supplements; extreme dietary restrictions
- Clinically significant sodium depletion as defined by a serum sodium level less than 130 mEq/L
- Clinically significant hyperkalemia as defined by a serum potassium level greater than 6.0 mEq/L. Clinically significant hypokalemia as defined by a serum potassium level less than 3.0 mEq/L
- Patients receiving any investigational therapy within one month of signing the informed consent form. Note that patients who have participated in previous telmisartan studies may participate in this study provided there has been at least one month between discontinuing the previous study and signing the consent for the present study
- Known hypersensitivity to any component of telmisartan
- Any other clinical condition which, in the opinion of the principal Investigator, would not allow safe completion of the protocol and safe administration of trial medication
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: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Telmisartan, low dose
3 weeks placebo run-in (normal diet), 1 week placebo run-in (controlled sodium diet), 2 weeks double-blind treatment ,1 week placebo wash-out (controlled sodium diet)
|
|
Experimental: Telmisartan, high dose
3 weeks placebo run-in (normal diet), 1 week placebo run-in (controlled sodium diet), 2 weeks double-blind treatment, 1 week placebo wash-out (controlled sodium diet)
|
|
Comparador de Placebo: Placebo
3 weeks placebo run-in (normal diet), 1 week placebo run-in (controlled sodium diet), 2 weeks double-blind treatment, 1 week placebo wash-out (controlled sodium diet)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Cumulative urinary sodium loss
Prazo: 0-4, 4-8, 8-24 hours post-dose at baseline, day 0, day 7 and 0-24 hours post-dose on days 1-6
|
0-4, 4-8, 8-24 hours post-dose at baseline, day 0, day 7 and 0-24 hours post-dose on days 1-6
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Cumulative urine sodium loss
Prazo: 0-24 hours post-dose on days 8-13 and 0-4, 4-8, 8-24 hours post-dose on day 14
|
0-24 hours post-dose on days 8-13 and 0-4, 4-8, 8-24 hours post-dose on day 14
|
Changes in body weight
Prazo: 24 hours post-dose on days -28, -21 to -14, -7, -1, 0, 7, 14 and 22
|
24 hours post-dose on days -28, -21 to -14, -7, -1, 0, 7, 14 and 22
|
Changes in plasma norepinephrine
Prazo: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Changes in renin activity
Prazo: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Changes in aldosterone
Prazo: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Changes in urine potassium
Prazo: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Changes in creatinine chloride
Prazo: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Changes in bicarbonate
Prazo: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Changes in uric acid
Prazo: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Cumulative urinary sodium gain during wash-out period
Prazo: 0-24 hours post-dose on days from day 15 to 22
|
0-24 hours post-dose on days from day 15 to 22
|
Changes in seated clinic blood pressure
Prazo: Baseline and day 14
|
Baseline and day 14
|
Changes in 24 hour ambulatory Blood Pressure (ABPM) after the first dose of telmisartan
Prazo: Day 0
|
Day 0
|
Number of patients with adverse events
Prazo: up to 50 days
|
up to 50 days
|
Number of patients with abnormal findings in physical examination
Prazo: Baseline and day 22
|
Baseline and day 22
|
Number of patients with abnormal findings in 12-lead electrocardiogram (ECG)
Prazo: Baseline and day 22
|
Baseline and day 22
|
Number of patients with abnormal changes in laboratory parameters
Prazo: Baseline and day 22
|
Baseline and day 22
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
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 fevereiro de 1999
Conclusão Primária (Real)
1 de julho de 1999
Datas de inscrição no estudo
Enviado pela primeira vez
26 de junho de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de junho de 2014
Primeira postagem (Estimativa)
27 de junho de 2014
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
8 de julho de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de julho de 2014
Última verificação
1 de julho de 2014
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 502.255
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 .