EUCTR2006-005261-19-PL进行中（未招募）1 期
A randomized, multicenter, double-blind, 6 week study to evaluate the dose response of valsartan on blood pressure reduction in children 1-5 years old with hypertension, followed by a 2 week placebo withdrawal period
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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
- 性别
- All
入选标准
- •1. Patients who are eligible and able to participate in the study and whose parent
- •(s)/guardian(s) consent in writing (written informed consent) to their doing so
- •after the purpose and nature of the investigation has been clearly explained.
- •2. Male or female between the ages of 1 to 5 years, at visit 1 with a documented
- •history of hypertension.
- •3. Must be able to swallow the liquid formulation of the study medication
- •4. Must be = 8 kg or = 40 kg
- •5. Patients, either naïve or treated, must have a documented history of a mean
- •seated systolic blood pressure (mean of three measurements), equal to or
- •greater than 95th percentile for age, gender and height (Appendix 3).
- •6. Patients with uncontrolled blood pressure, receiving background antihypertensive
- •therapy, may continue on this therapy provided there is no change in dosing
- •7. Patient that has had a previous solid organ transplantation more than 1 year
- •ago. Patient must be on stable doses of immunosuppressive therapy and
- •deemed clinically stable by the clinician. Stable doses of immunosuppressive
- •therapy are defined as no change in frequency or total daily doses of
- •immunosuppressive therapy for at least 3 months prior to screening. Doses of
- •immunosuppressive therapy must be maintained throughout Periods 1 and 2 of
- •8. Parent(s)/guardian(s) are able to follow verbal and/or written instructions in the
- •local language.
- •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
- •For full list, please refer to protocol.
- •1. Patients whose mean seated systolic blood pressure (mean of three
- •measurements), at the baseline visit (Visit # 2) is = 25% higher than the 95th
- •percentile for age, gender and height see Appendix 3.
- •2. Physical examination of patient demonstrates abnormalities that would make
- •this study medically hazardous to the patient.
- •3. Patients with background ARB therapy.
- •4. Patients that demonstrate any clinically significant abnormalities or clinically
- •noteworthy abnormal laboratory values (other than those relating to renal
- •function), including but not limited to the following:
- •AST/SGOT or ALT/SGPT > 3 times the upper limit of the reference range
- •Total bilirubin > 2 times the upper limit of the reference range
- •Creatinine clearance < 30 mL/min/1.73m² (calculated using Modified Schwartz
- •formula to estimate glomerular filtration rate [GFR], see section 7.5.5 for
- •formula, based on the serum creatinine concentration obtained at Visit 1
- •(Screening).
- •WBC count < 3000/mm³
- •Platelet count < 100,000/mm³
- •Serum potassium > upper limit of the reference range
- •5. Patients that demonstrate clinically significant ECG abnormalities other than
- •those associated with left ventricular hypertrophy and AV block controlled with a
- •6. Patients that have coarctation of the aorta with a gradient of = 30 mm Hg, or
- •renal artery stenosis.
- •7. Patient that has any clinically significant unstable medical condition or chronic
- •disease that would put the patient at risk of experiencing an adverse event
- •associated with the expected pharmacodynamic effects of the study medication.
- •8. Patient that has experienced a significant clinical illness within 10 days prior to
- •baseline visit.
- •9. Patient that is known to have tested positive for the hepatitis B surface antigen
- •or hepatitis C antibody.
- •10. Patient that is known to have tested seropositive for the human
- •immunodeficiency virus (HIV) or patient is concomitantly receiving anti-retroviral
研究者
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