Treatment of Pediatric Hypertension With Altace Trial

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00044265

Collaborator

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

310

Enrollment

Locations

28.1

Duration (Months)

10.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: ramipril	Phase 4

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2002

Study Completion Date :

Nov 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	Sante Los Angeles	Los Angeles	California	United States	90010
3	Neufeld Medical Group	Los Angeles	California	United States	90048
4	UCLA Medical Center	Los Angeles	California	United States	90095
5	Medical College of Georgia	Augusta	Georgia	United States	30912
6	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96813
7	Nephrology and Hypertension Consultants	Park Ridge	Illinois	United States	60068
8	University of Louisville	Louisville	Kentucky	United States	40202
9	Tulane University Health Sciences Center	New Orleans	Louisiana	United States	70112
10	University of Maryland	Baltimore	Maryland	United States	21201
11	Children's Hospital of Michigan	Detroit	Michigan	United States	48201
12	Univ of Missouri, Children's Mercy Hospital and Clinics	Kansas City	Missouri	United States	64108
13	St. Louis Children's Hospital	St. Louis	Missouri	United States	63110
14	Montefiore Medical Center c/o BRANY	Bronx	New York	United States	10467
15	North Shore Univ Hospital c/o BRANY	Great Neck	New York	United States	11021
16	Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
17	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106
18	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
19	PCTI at Columbus Children's Hospital	Columbus	Ohio	United States	43205
20	Oregon Health and Science University	Portland	Oregon	United States	97201
21	Hershey Medical Center	Hershey	Pennsylvania	United States	17033
22	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
23	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
24	The Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
25	Le Bonheur Children's Hospital - Univ of Tennessee	Memphis	Tennessee	United States	38103
26	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
27	Texas Children's Hospital	Houston	Texas	United States	77030
28	University of Texas Medical Center	Houston	Texas	United States	77030
29	University of Virginia	Charlottesville	Virginia	United States	22908
30	University of Wisconsin	Madison	Wisconsin	United States	53792