Treatment of Pediatric Hypertension With Altace Trial - Full Text View

Sponsor:	King Pharmaceuticals
Collaborator:	Wyeth
Information provided by:	King Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00044265

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: ramipril	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Ramipril

U.S. FDA Resources

Further study details as provided by King Pharmaceuticals:

Estimated Enrollment:	310
Study Start Date:	July 2002
Estimated Study Completion Date:	November 2004

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

Ages Eligible for Study:	6 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044265

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Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
Neufeld Medical Group
Los Angeles, California, United States, 90048
Sante Los Angeles
Los Angeles, California, United States, 90010
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Hawaii
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96813
United States, Illinois
Nephrology and Hypertension Consultants
Park Ridge, Illinois, United States, 60068
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Missouri
Univ of Missouri, Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States, 64108
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
United States, New York
Montefiore Medical Center c/o BRANY
Bronx, New York, United States, 10467
North Shore Univ Hospital c/o BRANY
Great Neck, New York, United States, 11021
United States, Ohio
PCTI at Columbus Children's Hospital
Columbus, Ohio, United States, 43205
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97201
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Le Bonheur Children's Hospital - Univ of Tennessee
Memphis, Tennessee, United States, 38103
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
University of Texas Medical Center
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

King Pharmaceuticals

Wyeth

More Information

No publications provided

Study ID Numbers:	K726-01-4002
Study First Received:	August 23, 2002
Last Updated:	October 12, 2005
ClinicalTrials.gov Identifier:	NCT00044265 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by King Pharmaceuticals:

ACE inhibitor
high blood pressure
pediatric

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Ramipril
Protease Inhibitors
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009