CTRI/2009/091/000045已完成3 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 - Nil
Merck Sharp Dohme Corp a subsidiary of Merck Co Inc0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patient is male or female from 6 months to 6 years of age. (Patient has not reached
- •7th birthday at time of randomization).
- •Patient age refers to chronological age not corrected age as in the prematurely born
- •infant population.
- •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.
排除标准
- •. 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: 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 patientâ??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). Exclusion Criteria Based on Concomitant Therapy
- •10. Patient is currently being treated with any of the following:
- •angiotensin II type I receptor blocker (ARB)
- •cyclosporine or tacrolimus (FK-506).
- •o Investigators may enter patients receiving other immunosuppressants provided
- •that the dose has been stable for at least 2 months prior to Visit 1. Patients
- •receiving systemic corticosteroids may be entered at the investigatorâ??s
- •discretion, provided that the dose has been stable for at least 2 months prior to
- •potassium-s
研究者
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