A Randomized, Double-Blind, Active Comparator Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan/HCTZ Combination as Compared to Losartan Monotherapy in Pediatric Patients With Essential Hypertension

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2007年8月17日最近更新: 2023年9月4日

试验速览

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•a) The patient is male or female and is between 6 and 17 years of age.
•b) The patient presents an essential hypertension with a SiSBP or
•SiDBP> 95th percentile but both SiSBP and SiDBP are <99th percentile + 5 mm Hg for their age / sex / height.
•c) The patient can take tablets.
•d) The parent or guardian has provided informed consent for their child to participate in the study. The patient´s consent will be obtained as required by local regulations.
•e) Patients should have a glomerular filtration rate ≥ 30 mL / min / 1.73 m2.

•a) The patient has a history of secondary hypertension of any etiology.
•b) The patient is pregnant or is breastfeeding.
•c) The patient has a history of severe or symptomatic hypertension within a period of 1 year before Visit 1.
•d) The patient has a history of heart failure, hemodynamically significant obstructive valvular disease, or cardiomyopathy.
•e) The patient has a clinically significant neurological, respiratory, gastrointestinal, hepatobiliary or hematologic disease.
•f) The patient has a known history of coarctation of the uncorrected aorta, bilateral renal artery stenosis, or renal artery stenosis in a single kidney.
•g) The patient has undergone a major organ transplant.
•h) The patient has clinically significant laboratory values outside the established normal range.
•i) The patient has a history of clinically significant rhythm disorders.
•j) The patient has a known sensitivity to losartan or another angiotensin II blocker, HCTZ, or a history of angioedema.
•k) The patient who probably does not stick to the study procedures, does not keep appointments, or is planning to move during
•I) The patient has any other factor that limits their participation.
•m) The patient has participated in another clinical trial within the last 28 days.

发起方

MERCK SHARP & DOHME PERU S.R.L.,