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Home > "T" Clinical Trials Conditions > Treatment of Pediatric Hypertension with Altace Trial  Treatment of Pediatric Hypertension with Altace Trial
Treatment of Pediatric Hypertension with Altace Trial
For Condition: Hypertension
Status: No longer recruiting
Sponsor(s): King Pharmaceuticals , Wyeth-Ayerst Research
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 6 Years/16 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 310
Location and Contact Information:
University of Maryland
Baltimore, Maryland, 21201
United States
Sante Los Angeles
Los Angeles, California, 90010
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
Le Bonheur Children's Hospital - Univ of Tennessee
Memphis, Tennessee, 38103
United States
PCTI at Columbus Children's Hospital
Columbus, Ohio, 43205
United States
Medical College of Georgia
Augusta, Georgia, 30912
United States
Oregon Health and Science University
Portland, Oregon, 97201
United States
Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
North Shore Univ Hospital c/o BRANY
Great Neck, New York, 11021
United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
United States
Univ of Missouri, Children's Mercy Hospital and Clinics
Kansas City, Missouri, 64108
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Nephrology and Hypertension Consultants
Park Ridge, Illinois, 60068
United States
University of Virginia
Charlottesville, Virginia, 22908
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
UCLA Medical Center
Los Angeles, California, 90095
United States
The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106
United States
University of Louisville
Louisville, Kentucky, 40202
United States
Neufeld Medical Group
Los Angeles, California, 90048
United States
University of Wisconsin
Madison, Wisconsin, 53792
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
University of Texas Medical Center
Houston, Texas, 77030
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
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96813
United States
Additional Information:
Study ID Numbers: K726-01-4002;
Study Start Date: July 2002
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044265
Other Hypertension Studies:
1. Hypertension Detection and Follow-up Program (HDFP)
2. Ambulatory Blood Pressure and Prognosis
3. Coronary Artery Risk Development in Young Adults (CARDIA)
4. Treatment of Hypertension
5. Study of the Response of Human Small Blood Vessels
Related Studies:
Other Hypertension Clinical Trials
Other Missouri Clinical Trials
Other Kansas City Clinical Trials
Treatment of Pediatric Hypertension with Altace Trial
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