Treatment of Pediatric Hypertension With Altace Trial - Full Text View

Sponsors and Collaborators:	King Pharmaceuticals 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

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Ramipril

U.S. FDA Resources

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

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

Show 30 Study Locations

Sponsors and Collaborators

King Pharmaceuticals

Wyeth

More Information

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

Keywords provided by King Pharmaceuticals:

ACE inhibitor
high blood pressure
pediatric

Study placed in the following topic categories:

Vascular Diseases
Ramipril
Hypertension

Additional relevant MeSH terms:

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

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009