EUCTR2015-003328-30-Outside-EU/EEA进行中（未招募）不适用
An Open-Label Study of the Single-Dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients with Hypertension
Daiichi Sankyo Pharma Development0 个研究点目标入组 24 人开始时间: 2015年7月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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.Age 12 months to 16 years, inclusive
- •2.Signed parental/guardian informed consent provided and assent from the subject if he/she was = 7 years old, or as required by the local IRB.
- •3.Glomerular filtration rate (GFR) = 30 mL/min/1.73 m2, estimated using the Schwartz equation
- •4.Sexually active females of child-bearing potential must have been practicing an acceptable method of birth control as defined as oral, injectable, or implantable hormonal contraceptives, intrauterine device, diaphragm plus spermicide, or female condom plus spermicide.
- •5.Negative serum beta-hCG at Screening and at administration (females of child bearing potential only)
- •6.Hypertension defined as one of the following:
- •- Current treatment for hypertension
- •- Systolic blood pressure (SBP) = 95th percentile
- •- SBP or diastolic blood pressure (DBP) = 90th percentile if diabetic or with a family history of hypertension
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •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.Clinically significant cardiac, gastrointestinal, hematological, hepatic or hepatobiliary, neurological, or pulmonary (except asthma) disorder
- •2.History of severe or symptomatic hypertension associated with stroke, seizures, encephalopathy, or other significant neurological findings within 2 years prior to Screening
- •3.Current treatment with more than 2 antihypertensive medications
- •4.Secondary hypertension from uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a single kidney
- •5.Serum albumin < 2.5 g/dL
- •6.Major organ or bone marrow transplantation except for kidney transplantation at least 6 months prior to Screening with stable renal function meeting the inclusion criteria
- •7.History of classic allergic response to the angiotensin II receptor antagonist class of drugs
- •8.Pregnancy or current lactation
- •9.Pertinent electrolyte disorders (serum sodium = 130 mEq/L, potassium = 5.5 mEq/L, for example)
- •10.Significant systemic disease that, in the judgment of the investigator, would disqualify the subject for this study
- •11.History of drug or alcohol abuse
- •12.Current treatment with any of the following medications: anticonvulsants, bile acid sequestrants, metoclopramide, major psychotropic agents, glucocorticosteroids (high-dose regimens, i.e., > 1 mg/kg given daily), prokinetic agents such as bethanechol or cisapride, antibiotics, except as approved by the Sponsor, any drug that might interfere with the absorption of OM
- •13.Any laboratory value at Screening outside the range of normal limits for the appropriate age group unless approved by the Principal Investigator and Sponsor
- •14.History of malignancy or exposure to cytotoxic agents within the last 6 months
- •15.Participation in another investigational new drug research study in the previous 30 days
研究者
相似试验
进行中（未招募）
不适用
An open label single dose pharmacokinetic study of Diamorphine Hydrochloride Nasal Spray (0.06mg/kg) in children - DIAPOP STUDYThe IMP is to be used as an analgesic for the relief of acute pain.MedDRA version: 12.0Level: LLTClassification code 10002182Term: AnalgesiaEUCTR2009-014983-20-GBWockhardt UK Limited
进行中（未招募）
不适用
Study of PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Male Chinese Subjects With Hemophilia AHemophilia AEUCTR2015-003685-88-Outside-EU/EEAPfizer Inc.13
进行中（未招募）
不适用
A single dose study of BeneFIX (nonacog alfa, recombinant factor IX) in male Chinese subjects with haemophilia B.EUCTR2015-003027-61-Outside-EU/EEAPfizer Inc.12
尚未招募
不适用
Bio availability study of Berberine in Manasamitra Vatakam: An ayurvedic herbomineral formulatioCTRI/2020/02/023267SRM Institute of Science and Technology
进行中（未招募）
不适用
Study Of Fesoterodine In Pediatric patients with Overactive Bladder, Ages 8-17 YearsOveractive bladder (OAB) and Neurogenic Detrusor Over activityEUCTR2014-004161-24-Outside-EU/EEAPfizer Inc. 235 East 42nd Street, New York, NY 1001721