EUCTR2008-004732-20-ES进行中（未招募）1 期
A Phase III, Randomized, Open-Label, Parallel-Group, Dose-Ranging Clinical Trial to Study the Safety and Efficacy of MK-0954/Losartan Potassium in Pediatric Patients With Hypertension Ensayo clínico de fase III, aleatorizado, abierto, de grupos paralelos y búsqueda de dosis, para estudiar la seguridad y la eficacia de MK-0954/losartán potásico en pacientes pediátricos con hipertensión - Safety and Efficacy of MK-0954 in Pediatric Pts with hypertension (ages 6 months - 6 years)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 101
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Patient is male or female from 6 months to 6 years of age. (Patient has not reached 7th birthday at time of randomization).
- •2. Patient is determined to be hypertensive according to one of the following criteria:
- •Patient is 6 months to <1 year old with a mean systolic blood pressure ? 95th
- •percentile based on gender and age.
- •Patient is ?1 year old with a mean systolic and/or diastolic blood pressure ? 95th
- •percentile based on gender, height and age.
- •Patient has co-morbidities or evidence of end organ damage with:
- •a. mean systolic blood pressure ? 90th percentile (6 month to <1 year old) based on
- •gender and age.
- •b. mean systolic and/or diastolic blood pressure ? 90th percentile (?1 year old)
- •based on gender, height, and age.
- •3. Informed parental consent has been obtained. Patient assent (when feasible) has been obtained as required by local regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient has a history of severe or symptomatic hypertension (e.g.hypertensioninduced seizures, stroke, encephalopathy) within 1 year of Visit 1 including patients whose SBP or DBP >99th percentile for gender/age/height plus 10 mm Hg.
- •2. Patient has a history of clinically significant heart failure, rhythm disturbance or
- •cardiomyopathy, or hemodynamically significant obstructive valvular disease.
- •3. Patient has clinically significant neurologic, respiratory, gastrointestinal, hepatobiliary, or hematologic disease.
- •4. Patient has a known history of uncorrected coarctation of the aorta, bilateral renal
- •artery stenosis, or renal artery stenosis to a single kidney.
- •5. Patient has a glomerular filtration rate of <30 ml/min/1.73m2 as determined by the
- •Schwartz Formula, based on the baseline serum creatinine (please see page 19 of protocol).
- •6. Patient has clinically significant laboratory values (as determined by the investigator) at Visit 1 outside of the established normal range including but not limited to any of the following parameters:
- •SGOT (AST) or SGPT (ALT) >2X the upper limit of normal
- •Total bilirubin or direct bilirubin >2X the upper limit of normal
- •White blood cell count <3000/mm3
- •Platelet count <100,000/mm3
- •Serum potassium ?5.5 mEq/L (?5.0 mEq/L if concomitantly
- •on ACE-inhibitor)
- •Serum sodium ?130 mEq/L
- •7. Patient has a known sensitivity to losartan or other ARB, or any history of
- •angioneurotic edema.
- •8. Patient or patient?s guardian who, in the opinion of the investigator, will not fully
- •cooperate, keep appointments, or who has been generally unreliable.
- •9. Patient has any other factors limiting participation (e.g., significant, concurrent, or
- •life-threatening diseases such as cancer, or mental incapacitation).
- •10. Patient is currently being treated with any of the following:
- •angiotensin II type I receptor blocker (ARB)
- •cyclosporine or tacrolimus (FK-506)
- •potassium-sparing diuretics (triamterene, amiloride, spironolactone and
- •eplerenone)
- •herbal supplements
- •pentamidine
- •trimethoprim
- •potassium supplements
- •chronic analgesics (NSAIDS, opioids, acetaminophen, aspirin)
- •11. Patient has used any investigational compounds within 30 days of Visit 1.
- •12. Patient has started any new concomitant antihypertensive medications within 30 days of Visit 1. Dosage of concomitant antihypertensive medications should be stable for 30 days before Visit 1.
研究者
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