PER-008-05已完成未知
Study of Varied Doses to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents with Hypertension
SANKYO PHARMA DEVELOPMENT,0 个研究点目标入组 0 人开始时间: 2005年8月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- •PATIENTS BETWEEN 6 AND 16 YEARS OLD
- •1) Provide informed consent and agree to attend all visits
- •2) The patient agrees to participate in the study.
- •3) Female or male patient whose age is> 6 to <17 years and whose weight is> 20 kg.
- •4) Adolescents taking oral contraceptives must have been under this therapy for at least 3 months.
- •5) Post-menarchal women should have a negative result on the pregnancy test
- •6) Hypertension, as defined by a TASps that is equal to or greater than the 95th percentile
- •7) Negative results in the analyzes of hepatitis B and C and negative result for the analysis of antibodies against HIV.
- •8) The patient is not a smoker, or has not smoked during the previous month.
- •PATIENTS BETWEEN 1 AND 5 YEARS
- •1) Provide informed consent and agree to attend all visits
- •2) Female or male patient whose age is> I year to <6 years and whose weight is> 5 kg.
- •3) Hypertension, as defined by a TASps that is equal to or greater than the 95th percentile
- •4) Negative results in the analyzes of hepatitis B and C and negative result for the analysis of antibodies against HIV.
- •5) The patient must not be a smoker.
排除标准
- •1) Any unstable medical condition or clinically significant chronic disease.
- •2) Significant clinical illness within the previous 10 days.
- •3) Clinically significant abnormality of the liver system or history of malabsorption or gastrointestinal surgery
- •4) Any of the following clinical laboratory abnormalities: AST / SGOT or ALT / SGPT> twice the maximum range limit, total bilirubin or direct bilimibin> twice the maximum limit, creatinine clearance <25 mL / min / l , 73m2, Hemoglobin <9 gm / dL, white blood cell count <3000 / mm ^, platelet count <1 OO.OOO/mm ^, serum potassium> maximum limit and serum albumin <2.5g / dL.
- •5) Known hypersensitivity to olmesartan medoxomil or its excipients
- •6) The patient has taken a research drug or participated in a research study within 30 days.
- •7) The patient is taking the excluded medications identified in Appendix 8.
- •8) Consumption of more than 180 mg of caffeine per day and / or the patient can not or does not want to abstain from drinking drinks containing caffeine or xanthine
- •9) Malignant hypertension
- •10) Any condition or reason that causes the investigator to believe that the patient is not suitable for the study.
- •11) The patient requires treatment for hypertension with more than 2 medications.
- •12) History of congestive heart failure, obstructive valvular disease or cardiomyopathy.
- •13) Coarctation of the uncorrected aorta, stenosis of the bilateral renal artery or stenosis of the unilateral renal artery in a solitary kidney.
- •14) Kidney transplant within the last 6 months or the patient is not on a stable therapy for rejection for at least 3
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