Description:

REducing Blood Pressure Variability in Essential Hypertension With RAmipril vErsus Nifedipine GITS Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02499822

Link:

https://clinicaltrials.gov/show/NCT02499822

Keywords:
Versions (1) ▾
  1. 4/17/19
Copyright Holder:
See clinicaltrials.gov
Uploaded on:

April 17, 2019

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License:
Creative Commons BY-NC 3.0
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Eligibility Hypertension NCT02499822

Eligibility Hypertension NCT02499822

  1. StudyEvent: Eligibility
    1. Eligibility Hypertension NCT02499822
Inclusion Criteria
male and female subjects
age 35-75 years
clinic systolic bp ≥140 mmhg and/or diastolic bp ≥ 90 mmhg (under no antihypertensive treatment)
daytime bp on ambulatory bp monitoring (abpm) ≥135 mmhg systolic and/or ≥85 mmhg diastolic (under no antihypertensive treatment)
home sbp standard deviation (sd) >7 mmhg and/or daytime ambulatory sbp sd >12 mmhg
patients may be included if untreated or, if treated with one antihypertensive drug or two drugs in low doses, after 2 weeks' washout period
written informed consent to participate in the study
Exclusion Criteria
subjects treated with ≥ 2 antihypertensive drugs (except those on two drugs in low doses)
treated subjects with on-treatment clinic bp ≥160 mmhg systolic and/or 100 mmhg diastolic
treated antihypertensive subjects in whom withdrawal of treatment is deemed unethical by the investigator (e.g. because of the existence of compelling indications other than hypertension for continuous use of previously used antihypertensive agent)
contraindications to study treatments as detailed in the relative summaries of medical product characteristics for ramipril (hypersensitivity to ramipril or any of the excipients or any other ace inhibitor, history of angioneurotic oedema, extracorporeal treatments leading to contact of blood with negatively charged surfaces, significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney, second and third trimesters of pregnancy, lactation, haemodynamically relevant renal artery stenosis, hypotensive or haemodynamically unstable patients) or nifedipine gits (known hypersensitivity to nifedipine or to any of the excipients, pregnancy before week 20 and during breastfeeding, cardiovascular shock, concomitant treatment with rifampicin, patients with a kock pouch)
cardiovascular diseases other than hypertension (coronary heart disease, heart failure or left ventricular systolic dysfunction of any degree, atrial fibrillation or frequent arrhythmias, valvular or congenital heart disease, cardiomyopathies, cerebrovascular disease, peripheral artery disease, aortic aneurysm)
chronic kidney disease
suspected or confirmed secondary hypertension
diabetes mellitus
subjects with conditions other than those mentioned above, where compelling indications for the use of any specific class of antihypertensive medication exist, according to current (e.g. european society of cardiology) guidelines
other conditions deemed relevant by the investigator (including respiratory disorders, liver disease, renal disease, thyroid disorders)
bmi ≥35 kg/m2
known severe obstructive sleep apnea (apnea-hypopnea index > 30 or use of cpap)
premenopausal women not using effective contraceptive methods
elevated probability of noncompliance with the study procedures