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	Treatment or Intervention	Phase
Hypertension	Drug: ramipril	Phase IV

Further Study Details: 

Expected Total Enrollment:  310

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.

Ages Eligible for Study:  6 Years   -   16 Years,  Genders Eligible for Study:  Both

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.

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

Study ID Numbers:  K726-01-4002
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  August 23, 2002
ClinicalTrials.gov Identifier:  NCT00044265
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08