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A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents

Last updated on February 17, 2019

FOR MORE INFORMATION
Study Location
UAMS College of Medicine/ Arkansas Children's Hospital
Little Rock, Arkansas, 72202 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-16 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. 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.

2. The subject can be safely withdrawn from antihypertensive medications during the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.

3. The subject is male or female age 6 to 16 years (inclusive), and weighs greater than
or equal to 20 kg.

4. 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.

5. 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Bilateral renal artery stenosis.

2. Uncorrected coarctation of the aorta or corrected coarctation with a right arm/right
leg blood pressure gradient greater than 10 mmHg.

3. Severe hypertension.

4. Renal transplantation or other previous solid organ transplantation less than 6 months
prior to entering the study.

5. Subjects with nephrotic syndrome not on stable maintenance therapy of prednisone or
cyclosporine.

6. 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.

7. 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.

8. History of pancreatitis (active or inactive).

9. Known sensitivity to angiotensin converting enzyme inhibitors or a history of
angioneurotic edema.

NCT00389519
Pfizer
Terminated
A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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