A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents
Condition: Hypertension
MeSH terms: Hypertension
Intervention: ramipril; placebo
Intervention description: once a day oral ramipril capsules given for 4 weeks; once a day oral placebo capsule for 4 weeks
Intervention MeSH terms: Ramipril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 422.0
Sex: All
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Hypertension/*etiology; Blood Pressure; Pediatric; Adolescent; Child

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.
    

Eligibility 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 The subject can be safely withdrawn from antihypertensive medications during the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.