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A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
UAMS College of Medicine/ Arkansas Children's Hospital
Little Rock, Arkansas, 72202 United States
Contact
1-800-718-1021
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

1. Previous, documented diagnosis of hypertension, or newly diagnosed hypertension
according to the fourth report on the diagnosis, evaluation and treatment of high
blood pressure in children and adolescents (United States). SiSBP greater than or
equal to the 95th percentile for age, gender, and height.

2. The subject can be safely withdrawn from antihypertensive medications during the
screening period, and if given placebo during the treatment period in the judgment of
the Investigator.

3. The subject is male or female age 6 to 16 years (inclusive), and weighs greater than
or equal to 20 kg.

4. Female subjects greater than or equal to 12 years of age, or who have had greater than
or equal to 1 menstruation must: (a) have a negative serum pregnancy test at screening
(i.e., subject is not pregnant), (b) not be lactating, and (c) use an acceptable
method of contraception.

5. Parents/guardians are able to demonstrate their ability to (a) use a home blood
pressure monitor supplied for the study to monitor their child's blood pressure, and
(2) mix and administer a liquid dose of study drug if needed.

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

1. Bilateral renal artery stenosis.

2. Uncorrected coarctation of the aorta or corrected coarctation with a right arm/right
leg blood pressure gradient greater than 10 mmHg.

3. Severe hypertension.

4. Renal transplantation or other previous solid organ transplantation less than 6 months
prior to entering the study.

5. Subjects with nephrotic syndrome not on stable maintenance therapy of prednisone or
cyclosporine.

6. 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.

7. Clinically significant hematologic, hepatobiliary, or renal disease including a
Schwartz formula GFR less than 40 mL/min/1.73 m2, and/or serum potassium (K+) greater
than 5.5 mEq/L.

8. History of pancreatitis (active or inactive).

9. Known sensitivity to angiotensin converting enzyme inhibitors or a history of
angioneurotic edema.

NCT00389519
Pfizer
Terminated
A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents

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A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Arm Study Assessing the Efficacy, Safety, and Dose-Response of Ramipril for the Treatment of Hypertension in Children and Adolescents
The primary purpose of this study is to evaluate the blood pressure lowering effects of ramipril, an FDA-approved drug for the treatment of hypertension in adults, in children and adolescents aged 6 to 16 years with hypertension.

Information is needed on the treatment of hypertension in children and adolescents with antihypertensive drugs like ramipril. The study will assess the safety and blood pressure effects of several doses of the antihypertensive drug ramipril in children and adolescents age 6-16 years. Approximately 450 children will be given placebo, or 1 of the 3 doses of ramipril. The treatment assigned will be done by chance, like flipping a coin. Approximately 120 study centers throughout the world will participate in the trial.

Each child will complete a 1- to 4-week Screening Period where they will stop taking their current blood pressure lowering drug(s), a 4-week Treatment Period where they will receive placebo or one of the ramipril doses, and a Follow-up visit 1 week after completion of the Treatment Period. Children diagnosed with hypertension according to the fourth report on the diagnosis, evaluation and treatment of high blood pressure in children and adolescents (U.S. report), will be included in the study if their blood pressure meets certain values.

Each child will complete a minimum of 6 and up to 9 clinic visits over the course of the study during which procedures and assessments of blood pressure and safety will be performed. In addition, a child's parents/guardians will be instructed to measure their child's blood pressure at home between clinic visits.

A planned interim analysis was performed after approximately 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
  • Drug: ramipril
    once a day oral ramipril capsules given for 4 weeks
    Other Name: Altace
  • Drug: placebo
    once a day oral placebo capsule for 4 weeks
  • Placebo Comparator: Placebo
    once per day
    Intervention: Drug: placebo
  • Experimental: ramipril low dose
    0.3125, 0.625, or 1.25 mg once a day, based on subject weight
    Intervention: Drug: ramipril
  • Experimental: ramipril mid dose
    1.25, 2.5, or 5 mg once a day, based on subject weight
    Intervention: Drug: ramipril
  • Experimental: ramipril high dose
    5, 10, or 20 mg once a day, based on subject weight
    Intervention: Drug: ramipril
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
422
November 2007
November 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Previous, documented diagnosis of hypertension, or newly diagnosed hypertension according to the fourth report on the diagnosis, evaluation and treatment of high blood pressure in children and adolescents (United States). SiSBP greater than or equal to the 95th percentile for age, gender, and height.
  2. The subject can be safely withdrawn from antihypertensive medications during the screening period, and if given placebo during the treatment period in the judgment of the Investigator.
  3. The subject is male or female age 6 to 16 years (inclusive), and weighs greater than or equal to 20 kg.
  4. Female subjects greater than or equal to 12 years of age, or who have had greater than or equal to 1 menstruation must: (a) have a negative serum pregnancy test at screening (i.e., subject is not pregnant), (b) not be lactating, and (c) use an acceptable method of contraception.
  5. Parents/guardians are able to demonstrate their ability to (a) use a home blood pressure monitor supplied for the study to monitor their child's blood pressure, and (2) mix and administer a liquid dose of study drug if needed.

Exclusion Criteria:

  1. Bilateral renal artery stenosis.
  2. Uncorrected coarctation of the aorta or corrected coarctation with a right arm/right leg blood pressure gradient greater than 10 mmHg.
  3. Severe hypertension.
  4. Renal transplantation or other previous solid organ transplantation less than 6 months prior to entering the study.
  5. Subjects with nephrotic syndrome not on stable maintenance therapy of prednisone or cyclosporine.
  6. 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.
  7. Clinically significant hematologic, hepatobiliary, or renal disease including a Schwartz formula GFR less than 40 mL/min/1.73 m2, and/or serum potassium (K+) greater than 5.5 mEq/L.
  8. History of pancreatitis (active or inactive).
  9. Known sensitivity to angiotensin converting enzyme inhibitors or a history of angioneurotic edema.
Sexes Eligible for Study: All
6 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Chile,   Colombia,   India,   Poland,   South Africa,   Turkey,   Ukraine,   United States
 
 
NCT00389519
K726-06-4003
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
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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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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