Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension

Daiichi Sankyo Pharma Development0 个研究点目标入组 362 人开始时间: 2015年7月28日最近更新: 2015年8月4日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 362

研究概览入排标准研究者记录与标识符相似试验

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

•Inclusion Criteria for Subjects 6 to 16 Years of Age
•1. Provided informed consent and agreed to attend all clinic visits. (An informed consent form [ICF] was approved by the IRB/IEC and was signed by the parent/legal guardian.)
•2. Subject assented to the study.
•3. Female or male subject who was 6 years to < 17 years of age and weighing 20 kg. (Note, a subject was considered 16 years of age until the day before their 17th birthday at the Screening Visit.)
•4. Adolescent females taking oral contraceptives had to be on therapy for at least 3 months before Screening. Not applicable to male subjects.
•5. Post-menarchal females had to have a negative urine pregnancy test result within 72 hours prior to receiving study drug. These subjects were not to become pregnant for the duration of the study and were to use acceptable contraception. Not applicable to male subjects.
•6. Hypertension defined as a SeSBP measuring at or above the 95th percentile (90th percentile for diabetics, subjects with glomerular kidney disease, or subjects with a family history of hypertension) for age, gender, and height while off any antihypertension medication. Subjects had to meet this requirement by Visit 1.2.
•7. Negative hepatitis B and C tests and a negative human immunodeficiency virus (HIV) antibody test.
•8. Subject was a non-smoker or had not smoked for the past month.
•Inclusion Criteria for Subjects 1 to 5 Years of Age
•1. Provided informed consent and agreed to attend all clinic visits. (An ICF was approved by the IRB/IEC and was signed by the parent/ legal guardian).
•2. Female or male subject = 1 year to < 6 years of age and had a weight of = 5 kg. Note: A subject was considered 5 years of age until the day before their 6th birthday at the Screening Visit.
•3. Hypertension as defined by a SeSBP measuring at or above the 95th percentile (90th percentile for diabetics, subjects with glomerular kidney disease, or subjects with a family history of hypertension) for age, gender, and height while off any antihypertensive medication. Subjects could continue their CCB and/or diuretic therapy if they satisfied the SeSBP criteria while on their medications. Subjects must have met this requirement by Visit 1.2.
•4. Negative hepatitis B and C tests and negative HIV antibody test.
•5. Subject was a non-smoker.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 362
•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. Had any clinically relevant unstable medical condition or chronic disease other than those associated with hypertension.
•2. Had significant clinical illness within 10 days prior to receiving the first dose of study medication (Day 1, Visit 2.0 of Period II).
•3. Had clinically relevant abnormality of the hepatic system or a history of malabsorption or previous gastrointestinal surgery that could affect drug absorption or metabolism.
•4. Had any of the following clinical laboratory abnormalities:
•-an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that was > 2 times the upper limit of the reference range;
•-a total bilirubin or direct bilirubin that was > 2 times the upper limit of the reference range;
•-a creatinine clearance that was < 25 mL/min/1.73m^2 (calculated using Modified Schwartz formula to estimate glomerular filtration rate [GFR]);
•-a hemoglobin that was < 9 g/dL;
•-a white blood cell (WBC) count that was < 3000/mm^3;
•-a platelet count that was < 100,000/ mm^3;
•-a serum potassium that was > upper limit of the reference range;
•-a serum albumin that was < 2.5 g/dL.
•5. Had known hypersensitivity to OM or its excipients, or other ACE inhibitors or angiotensin receptor blocking drugs.
•6. Had taken an investigational drug or participated in an investigational study within 30 days prior to study drug administration.
•7. Taking excluded medication (See Section 6.4.7).
•8. Consumed more than 180 mg of caffeine per day (or seven 6-ounce cans of cola drink) and/or was unable or unwilling to refrain from ingesting caffeine or xanthine-containing beverages (tea, coffee, cola) from 24 hours prior to dosing through study completion.
•9. Had malignant hypertension (i.e., hypertension associated with symptoms of malignant hypertension per investigator’s judgment; or SeSBP and/or SeDBP that was >2 SDs above the 99th percentile [SeSBP that was 22 mm Hg above the 99th percentile and SeDBP that was 12 mm Hg above the 99th percentile] for subject’s age/height/gender).
•10. Had any condition or reason that caused the investigator to feel that the subject was not suited for the study.
•11. Required more than 2 medications for treatment of hypertension.
•12. Had a history of congestive heart failure, obstructive valvular disease, or cardiomyopathy.
•13. Had uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a solitary kidney.
•14. Had a renal transplant within the previous 6 months or, if the subject had a transplant more than 6 months before, was not on a stable anti-rejection therapy regimen for at least 3 months prior to screening.
•15. Had severe nephritic syndrome not in remission.

研究者

发起方

Daiichi Sankyo Pharma Development

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