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

NCT00389519

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

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 The subject can be safely withdrawn from antihypertensive medications during the screening period, and if given placebo during the treatment period in the judgment of the Investigator.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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 29, 2010)
422
Original Enrollment  ICMJE
 (submitted: October 18, 2006)
240
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Chile,   Colombia,   India,   Poland,   South Africa,   Turkey,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00389519
Other Study ID Numbers  ICMJE K726-06-4003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pfizer
Verification Date June 2012

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