Treatment of Pediatric Hypertension With Altace Trial
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
1 other identifier
interventional
310
1 country
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hypertension
Started Jul 2002
Typical duration for phase_4 hypertension
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 23, 2002
CompletedFirst Posted
Study publicly available on registry
August 26, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedJune 7, 2012
June 1, 2012
August 23, 2002
June 6, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Wyeth is now a wholly owned subsidiary of Pfizercollaborator
Study Sites (30)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Sante Los Angeles
Los Angeles, California, 90010, United States
Neufeld Medical Group
Los Angeles, California, 90048, 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
North Shore Univ Hospital c/o BRANY
Great Neck, New York, 11021, United States
Montefiore Medical Center c/o BRANY
The Bronx, New York, 10467, United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
PCTI at Columbus Children's Hospital
Columbus, Ohio, 43205, United States
Oregon Health and Science University
Portland, Oregon, 97201, United States
Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 23, 2002
First Posted
August 26, 2002
Study Start
July 1, 2002
Study Completion
November 1, 2004
Last Updated
June 7, 2012
Record last verified: 2012-06