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.

• Register: EUCTR
• Last refreshed on: 9 March 2015
• Main ID: EUCTR2009-017028-22-SK
• Date of registration: 11/06/2010
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: 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.
• Scientific title: 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.
• Date of first enrolment: 24/09/2010
• Target sample size: 275
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017028-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: yes Other:

Countries of recruitment

Belgium, Germany, Hungary, Poland, Slovakia

Contacts

• Name: DRA Department
• Affiliation: Novartis Slovakia s.r.o.

• Name: DRA Department
• Affiliation: Novartis Slovakia s.r.o.

Key inclusion & exclusion criteria

Inclusion criteria:
Male or female, ages 6 years -17 years and 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 parent(s)/guardian(s) 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:
• 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
• Current treatment with atorvastatin, cholestyramine or colestipol resins, monoamine oxidase (MAO) inhibitors, ketoconazole, itraconazole, or antiarrhythmic medications (other than digoxin)
• 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

hypertension
MedDRA version: 17.0 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders

Intervention(s)

Product Name: aliskiren
Product Code: SPP100
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: aliskiren
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.125 mg-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The primary endpoint for this short-term study is efficacy and safety.

Main Objective: In Phase 1, to evaluate the dose response of aliskiren in msSBP change at end of Phase 1 from the baseline, as measured by office blood pressure reading, in
children 6 to 17 years old with hypertension.
In Phase 2 (placebo controlled phase), to evaluate pooled treatment effect of aliskiren in msSBP change at end of Phase 2 from the end of Phase 1, compared to
placebo pooled from corresponding arms, as measured by office blood pressure reading, in children 6 to 17 years old with hypertension.

Secondary Objective: To evaluate the safety and tolerability of short-term (8 weeks) administration of aliskiren in children aged 6 to 17 years with hypertension.
In Phase 1, to evaluate the dose response of aliskiren in msDBP and MAP change at end of Phase 1 from the baseline, as measured by office blood pressure reading, in
children 6 to 17 years old with hypertension.
In Phase 2 (placebo controlled phase), to evaluate pooled treatment effect of aliskiren in msDBP and MAP change at end of Phase 2 from the end of Phase 1, compared to placebo pooled from corresponding arms, as measured by office blood pressure reading, in children 6 to 17 years old with hypertension.
To explore the effect of aliskiren at low, mid and high doses on the 24 hour ambulatory blood pressure monitoring (ABPM) profiles.
To explore the relationship between change in plasma renin activity (PRA) and the dose of aliskiren, at the end of Phase 1, in children aged 6 to 17 years with hypertension

Secondary ID(s)

CSPP100A2365

2009-017028-22-HU

Source(s) of Monetary Support

Novartis Pharma Services AG.