Treatment of Pediatric Hypertension With Altace Trial

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00044265
First received: August 23, 2002
Last updated: June 6, 2012
Last verified: June 2012

August 23, 2002
June 6, 2012
July 2002
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Complete list of historical versions of study NCT00044265 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension
Drug: ramipril
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
310
November 2004
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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.
Both
6 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00044265
K726-01-4002
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Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Pfizer
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP