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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00389519
Recruitment Status : Terminated (A planned interim analysis was performed after approx. 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis.)
First Posted : October 19, 2006
Results First Posted : May 19, 2010
Last Update Posted : June 11, 2012
Sponsor:
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: ramipril Drug: placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ramipril

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
once per day
 Drug: placebo
once a day oral placebo capsule for 4 weeks
Experimental: ramipril low dose
0.3125, 0.625, or 1.25 mg once a day, based on subject weight
 Drug: ramipril
once a day oral ramipril capsules given for 4 weeks
Other Name: Altace
Experimental: ramipril mid dose
1.25, 2.5, or 5 mg once a day, based on subject weight
 Drug: ramipril
once a day oral ramipril capsules given for 4 weeks
Other Name: Altace
Experimental: ramipril high dose
5, 10, or 20 mg once a day, based on subject weight
 Drug: ramipril
once a day oral ramipril capsules given for 4 weeks
Other Name: Altace


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure [ Time Frame: Baseline to 4 weeks ]
    Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo


Secondary Outcome Measures :
  1. Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure [ Time Frame: Baseline to 4 weeks ]
    Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo

  2. Change From Baseline to 4 Weeks in Serum Creatinine [ Time Frame: Baseline up to 4 weeks ]
    Value at end of treatment (up to 4 weeks) minus value at baseline

  3. Change From Baseline to 4 Weeks in Serum Potassium [ Time Frame: Baseline up to 4 weeks ]
    Value at end of treatment (up to 4 weeks) minus value at baseline

  4. Change From Baseline to 4 Weeks in Schwartz Formula Glomerular Filtration Rate (GFR) [ Time Frame: Baseline up to 4 weeks ]
    Value at end of treatment (up to 4 weeks) minus value at baseline; GFR is a measure of kidney function.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389519


Locations
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Sponsors and Collaborators
Pfizer
More Information
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Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00389519    
Other Study ID Numbers: K726-06-4003
First Posted: October 19, 2006    Key Record Dates
Results First Posted: May 19, 2010
Last Update Posted: June 11, 2012
Last Verified: June 2012
Keywords provided by Pfizer:
Hypertension/*etiology
Blood Pressure
Pediatric
Adolescent
Child
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents