Treatment of Pediatric Hypertension With Altace Trial
Information source: King Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: ramipril (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: King Pharmaceuticals
Summary
Ramipril is an ACE inhibitor that has been marketed in the US for the treatment of
hypertension since 1991. It has been shown to be effective in reducing both systolic and
diastolic blood pressure in adults when used once daily. ACE inhibitors are frequently used
to treat hypertension in children, however ramipril has not been extensively tested in
children, and information regarding the efficacy and safety would therefore be of benefit to
children. This study is designed to demonstrate the efficacy and safety of ramipril in the
treatment of hypertension in children ages 6 through 16 years.
Clinical Details
Official title: A Dose Escalation, Randomized, Double-Blind Withdrawal Study of the Efficacy, Dose-Response, and Safety of Ramipril for the Treatment of Hypertension in Children and Adolescents
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Detailed description:
In adults, common side effects include persistent dry mouth, dizziness, fatigue, and
headache. Rare cases of angioedema have been reported. When used in pregnancy during the
second and third trimesters, ACE inhibitors can cause injury and even death to the developing
fetus. When pregnancy is detected, ramipril should be discontinued as soon as possible.
Ramipril is contraindicated in patients who are hypersensitive to the product or have a
history of angioedema related to previous treatment with an ACE inhibitor.
Eligibility
Minimum age: 6 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Males or females age 6 to 16 years. All female subjects ≥ 8 years of age must have a
negative urine pregnancy test and must use an acceptable method of contraception,
including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral
contraceptive, for the duration of the study.
- Weight ≥ 20 kg.
- Parents/guardians must be able to demonstrate their ability to use the home blood
pressure device to monitor blood pressure.
- Sitting systolic blood pressure or sitting diastolic blood pressure ≥ the 95th
percentile for age, gender and height; or diabetes mellitus or chronic renal
insufficiency (as evidenced by GFR 40-70 mL/min/1. 73 m2) and a sitting systolic blood
pressure or sitting diastolic blood pressure ≥ the 90th percentile for age, gender,
and height.
Exclusion criteria:
- Severe hypertension documented by (1) Sitting systolic blood pressure or sitting
diastolic blood pressure more than 20 mmHg above the 95th percentile for age, gender,
and height without antihypertensive therapy, (2) Sitting systolic blood pressure or
sitting diastolic blood pressure more than 12 mmHg above the 95th percentile for age,
gender, and height while receiving active therapy, or (3) hypertensive encephalopathy
within the previous 5 months.
- Currently receiving more than one antihypertensive medication including: ACE
inhibitors, angiotensin receptor inhibitors, beta blockers, calcium channel blockers,
diuretics.
- Receiving lithium, potassium supplements, monoamine oxidase inhibitors, or major
tranquilizers (Note: Stimulant medications for behavioral disorders, corticosteroids,
and non-steroidal anti-inflammatory agents for chronic pain management are permitted
during the trial provided the subject’s dosage is anticipated to remain unchanged
throughout the duration of the study.)
- 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.
Locations and Contacts
University of Alabama at Birmingham, Birmingham, Alabama 35233, United States
Neufeld Medical Group, Los Angeles, California 90048, United States
Sante Los Angeles, Los Angeles, California 90010, United States
UCLA Medical Center, Los Angeles, California 90095, United States
Medical College of Georgia, Augusta, Georgia 30912, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii 96813, United States
Nephrology and Hypertension Consultants, Park Ridge, Illinois 60068, United States
University of Louisville, Louisville, Kentucky 40202, United States
Tulane University Health Sciences Center, New Orleans, Louisiana 70112, United States
University of Maryland, Baltimore, Maryland 21201, United States
Children's Hospital of Michigan, Detroit, Michigan 48201, United States
Univ of Missouri, Children's Mercy Hospital and Clinics, Kansas City, Missouri 64108, United States
St. Louis Children's Hospital, St. Louis, Missouri 63110, United States
Montefiore Medical Center c/o BRANY, Bronx, New York 10467, United States
North Shore Univ Hospital c/o BRANY, Great Neck, New York 11021, United States
PCTI at Columbus Children's Hospital, Columbus, Ohio 43205, United States
University Hospitals of Cleveland, Cleveland, Ohio 44106, United States
Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States
Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States
Oregon Health and Science University, Portland, Oregon 97201, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania 19107, United States
Hershey Medical Center, Hershey, Pennsylvania 17033, United States
The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States
The Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States
Le Bonheur Children's Hospital - Univ of Tennessee, Memphis, Tennessee 38103, United States
Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States
Texas Children's Hospital, Houston, Texas 77030, United States
University of Texas Medical Center, Houston, Texas 77030, United States
University of Virginia, Charlottesville, Virginia 22908, United States
University of Wisconsin, Madison, Wisconsin 53792, United States
Additional Information
Starting date: July 2002
Ending date: November 2004
Last updated: October 12, 2005
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