Treatment of Pediatric Hypertension With Altace Trial

Completed · Phase 4

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00044265

Run by

Pfizer

People needed

310

Starts

2002-07-01

Expected to finish

2004-11-01

Last updated by the study team

2012-06-07

Who can join

Age: 6 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Sante Los Angeles — Los Angeles, California, United States
• Neufeld Medical Group — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
• Nephrology and Hypertension Consultants — Park Ridge, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Univ of Missouri, Children's Mercy Hospital and Clinics — Kansas City, Missouri, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• North Shore Univ Hospital c/o BRANY — Great Neck, New York, United States
• Montefiore Medical Center c/o BRANY — The Bronx, New York, United States
• Children's Hospital Medical Center — Cincinnati, Ohio, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• PCTI at Columbus Children's Hospital — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Hershey Medical Center — Hershey, Pennsylvania, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• The Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Le Bonheur Children's Hospital - Univ of Tennessee — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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