A multicenter, randomized, double-blind, 8 week study to evaluate the dose response, efficacy and safety of aliskiren in pediatric hypertensive patients 6-17 years of age.

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 275

Inclusion Criteria

Male or female, ages 6 years to 17 years 6 months at randomization, with a documented diagnosis of hypertension as defined in the NHLBI 4th Report, 2004
• Must be = 20 kg and = 150 kg at randomization (Visit 2)
• Must be able to safely wash out prior antihypertensive therapy for a minimum of 7 days if already receiving treatment
• Must be able to swallow minitablets (2mm in diameter) administered in soft food
• msSBP (mean of 3 measurements) must be = 95th percentile for age, gender and height, at Visit 2 (randomization) measurement as defined by the NHLBI 4th Report, 2004
• Patients who are eligible and able to participate in the study and whose parents/guardian consent in writing (written informed consent) to their doing so after the purpose and nature of the investigation has been clearly explained to them. (An assent may be required for some patients depending upon their age and local requirements regarding assents)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Any clinically significant abnormalities or clinically noteworthy abnormal lab values as defined in the protocol
• Renal artery stenosis
• History of angioedema
• Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or
obstructive valvular disease
• msSBP = 25% above the 95th percentile
• Second or third degree heart block without a pacemaker
• Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening, or any symptomatic arrhythmia during the 12 months prior to Visit 1
• Previous solid organ transplantation
• Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
• Human immunodeficiency virus (HIV) by history and/or the patient is concomitantly receiving anti-retroviral therapy for the treatment of HIV
• Any clinically significant unstable medical condition or chronic disease that would put the patient at risk of experiencing an adverse event associated with the expected pharmacodynamic effects of the study medication
• Any surgical or medical condition or concomitant medication which might significantly alter the absorption, distribution, metabolism, or excretion of study medication
• History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
• History or evidence of drug or alcohol abuse within the last 12 months
• Females of child-bearing potential, defined as all females aged 8 years and above,
physiologically capable of becoming pregnant, including women whose lifestyle or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they are willing to use an acceptable, hormonal or non-hormonal form of birth control, including for non-hormonal forms of birth control, double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap), or abstinence
• Pregnant or nursing (lactating) women
• History of hypersensitivity to study medication or to any drug of similar chemical class
• Participation in any investigational drug study within 30 days
• Any condition that in the opinion of the investigator would confound the evaluation and interpretation of efficacy and/or safety data

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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