MedPath

Treatment of Pediatric Hypertension With Altace Trial

Phase 4
Completed
Conditions
Hypertension
Registration Number
NCT00044265
Lead Sponsor
Pfizer
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
310
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (30)

Hershey Medical Center

🇺🇸

Hershey, Pennsylvania, United States

PCTI at Columbus Children's Hospital

🇺🇸

Columbus, Ohio, United States

The Children's Hospital of Philadelphia

🇺🇸

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

🇺🇸

Philadelphia, Pennsylvania, United States

University of Virginia

🇺🇸

Charlottesville, Virginia, United States

University Hospitals of Cleveland

🇺🇸

Cleveland, Ohio, United States

University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

Neufeld Medical Group

🇺🇸

Los Angeles, California, United States

Sante Los Angeles

🇺🇸

Los Angeles, California, United States

Medical College of Georgia

🇺🇸

Augusta, Georgia, United States

UCLA Medical Center

🇺🇸

Los Angeles, California, United States

Kapiolani Medical Center for Women and Children

🇺🇸

Honolulu, Hawaii, United States

Tulane University Health Sciences Center

🇺🇸

New Orleans, Louisiana, United States

University of Louisville

🇺🇸

Louisville, Kentucky, United States

Nephrology and Hypertension Consultants

🇺🇸

Park Ridge, Illinois, United States

University of Maryland

🇺🇸

Baltimore, Maryland, 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

Montefiore Medical Center c/o BRANY

🇺🇸

Bronx, New York, United States

Children's Hospital of Michigan

🇺🇸

Detroit, Michigan, United States

North Shore Univ Hospital c/o BRANY

🇺🇸

Great Neck, New York, United States

Children's Hospital Medical Center

🇺🇸

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

🇺🇸

Cleveland, Ohio, United States

Oregon Health and Science University

🇺🇸

Portland, Oregon, United States

The Children's Hospital of Pittsburgh

🇺🇸

Pittsburgh, Pennsylvania, United States

Le Bonheur Children's Hospital - Univ of Tennessee

🇺🇸

Memphis, Tennessee, United States

Vanderbilt University Medical Center

🇺🇸

Nashville, Tennessee, United States

University of Texas Medical Center

🇺🇸

Houston, Texas, United States

Texas Children's Hospital

🇺🇸

Houston, Texas, United States

University of Wisconsin

🇺🇸

Madison, Wisconsin, United States

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