An Open-label Study of the Single-dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients With Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)
研究概览
简要总结
Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 months to 16 years inclusive
- •Signed parental/guardian informed consent and assent from the subject
- •Current treatment for hypertension, or, if not currently treated for hypertension, systolic blood pressure (SBP) greater than or equal to 95th percentile for gender and height-for-age, or, if not currently treated for hypertension, systolic blood pressure or diastolic blood pressure greater than or equal to 90th percentile for gender and height-for-age and diabetic or having a family history of hypertension
- •Glomerular filtration rate (GFR) greater than or equal to 30 mL/min/1.73 m2, estimated using the Schwartz equation
- •Sexually active females of child-bearing potential must be practicing an acceptable method of birth control
- •Negative serum beta-human chorionic gonadotropin at screening and at admission (female of child-bearing potential only)
排除标准
- •Clinically significant cardiac, gastrointestinal, hematologic, hepatic or hepatobiliary, neurologic, or pulmonary (except asthma) disorder
- •History of severe or symptomatic hypertension associated with stroke, seizures, encephalopathy, or other significant neurologic findings within 1 year prior to screening
- •Current treatment with more than 2 antihypertensive medications
- •Secondary hypertension from uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a single kidney
- •Serum albumin < 2.5 g/dL
- •Major organ or bone marrow transplantation except for prior kidney transplantation of at least 6 months and with stable renal function meeting the inclusion criteria
研究组 & 干预措施
Olmesartan
Children less than 6 years old received 0.3 mg/kg. Children 6 years old or older received 40 mg, if they weighed 35 kg or more; 20 mg if they weighed less than 35 kg.
干预措施: Olmesartan medoxomil (Drug)
结局指标
主要结局
For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)
时间窗: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity
时间窗: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Elimination Constant Rate
时间窗: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase
时间窗: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Foe Olmesartan, the Time of Maximum Plasma Concentration
时间窗: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Elimination Half-life of the Drug in Plasma
时间窗: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Apparent Oral Clearance
时间窗: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Apparent Oral Volume of Distribution
时间窗: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
次要结局
未报告次要终点