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Treatment of Pediatric Hypertension With Altace Trial

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NCT00044265

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-16 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00044265
Pfizer
Completed
Treatment of Pediatric Hypertension With Altace Trial

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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
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Hypertension
Drug: ramipril
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
310
November 2004
Not Provided

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.
Sexes Eligible for Study: All
6 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00044265
K726-01-4002
Not Provided
Not Provided
Not Provided
Not Provided
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

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