A multicenter, randomized, double-blind, parallel-group, evaluation of 12 weeks of valsartan compared to enalapril on sitting systolic blood pressure in children 6 to 17 years of age with hypertension - ND

• Conditions: hypertension; MedDRA version: 9.1Level: LLTClassification code 10020772Term: Hypertension

• Registration Number: EUCTR2006-005260-88-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Male or female, ages 6-17 at randomization, with a documented history of hypertension Must be able to swallow a pill Must be >= 18 kg or <= 160 kg at randomization (Visit 2) Must be able to safely wash out antihypertensive therapy MSSBP (mean of 3 measurements) must be >= 95th percentile, for age, gender and height, at Visit 2 (randomization), by office blood pressure measurement 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 to them. (An assent will be required for some patients depending upon their age and local requirements regarding assents)
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

Exclusion Criteria

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]), based on the serum creatinine concentration obtained at the screening visit WBC count <3000/mm³ Platelet count <100,000/mm³ Serum potassium >5.3 mEq/L Renal artery stenosis Current diagnosis of heart failure (NYHA Class II-IV). MSSBP >= 25% above the 95th percentile Patient that demonstrates clinically significant ECG abnormalities other than those associated with left ventricular hypertrophy and concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. Patients with second or third degree heart block without a pacemaker. Previous solid organ transplantation except renal, liver or heart transplantation. Renal, liver or heart transplant must have occurred at least 6 months prior to enrollment. Patient must be on stable doses of immunosuppressive therapy for 3 months and deemed clinically stable by the investigator. Seropositive for the human immunodeficiency virus (HIV) and patient is concomitantly receiving anti-retroviral therapy 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 Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following: History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection. Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1. Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Visit 1. Active pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase. History of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt. Current obstruction of the urinary tract or difficulty in voiding due to mechanical or inflammatory conditions which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator. Known or suspected contraindications to the study medications, including history or allergy to ARBs and/or ACEs History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin History or evidence of drug or alcohol abuse within the last 12 months. (Patients who smoke are eligible for the study.) Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose lifestyle or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they are willing to use an acceptable, hor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified