Status:
TERMINATED
A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents
Lead Sponsor:
Pfizer
Conditions:
Hypertension
Eligibility:
All Genders
6-16 years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to evaluate the blood pressure lowering effects of ramipril, an FDA-approved drug for the treatment of hypertension in adults, in children and adolescents aged 6 t...
Detailed Description
Information is needed on the treatment of hypertension in children and adolescents with antihypertensive drugs like ramipril. The study will assess the safety and blood pressure effects of several dos...
Eligibility Criteria
Inclusion
- Previous, documented diagnosis of hypertension, or newly diagnosed hypertension according to the fourth report on the diagnosis, evaluation and treatment of high blood pressure in children and adolescents (United States). SiSBP greater than or equal to the 95th percentile for age, gender, and height.
- The subject can be safely withdrawn from antihypertensive medications during the screening period, and if given placebo during the treatment period in the judgment of the Investigator.
- The subject is male or female age 6 to 16 years (inclusive), and weighs greater than or equal to 20 kg.
- Female subjects greater than or equal to 12 years of age, or who have had greater than or equal to 1 menstruation must: (a) have a negative serum pregnancy test at screening (i.e., subject is not pregnant), (b) not be lactating, and (c) use an acceptable method of contraception.
- Parents/guardians are able to demonstrate their ability to (a) use a home blood pressure monitor supplied for the study to monitor their child's blood pressure, and (2) mix and administer a liquid dose of study drug if needed.
Exclusion
- Bilateral renal artery stenosis.
- Uncorrected coarctation of the aorta or corrected coarctation with a right arm/right leg blood pressure gradient greater than 10 mmHg.
- Severe hypertension.
- Renal transplantation or other previous solid organ transplantation less than 6 months prior to entering the study.
- Subjects with nephrotic syndrome not on stable maintenance therapy of prednisone or cyclosporine.
- A history of cardiomyopathy, clinically significant structural heart disease, or atrioventricular conduction disturbance, sick sinus syndrome, atrial flutter, atrial fibrillation, clinically significant bradycardia or an accessory bypass tract, or clinical symptoms of congestive heart failure.
- Clinically significant hematologic, hepatobiliary, or renal disease including a Schwartz formula GFR less than 40 mL/min/1.73 m2, and/or serum potassium (K+) greater than 5.5 mEq/L.
- History of pancreatitis (active or inactive).
- Known sensitivity to angiotensin converting enzyme inhibitors or a history of angioneurotic edema.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT00389519
Start Date
October 1 2006
End Date
November 1 2007
Last Update
June 11 2012
Active Locations (100)
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1
UAMS College of Medicine/ Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Woodland International Research Group, LLC
Little Rock, Arkansas, United States, 72211
3
Impact Clinical Research
Beverly Hills, California, United States, 90211
4
Neufeld Medical Group
Los Angeles, California, United States, 90048