An extension study to evaluate long term growth and development of hypertensive children 6-17 years of age previously treated with a substance called aliskire
- Conditions
- HypertensionMedDRA version: 14.1Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 14.1Level: PTClassification code 10039834Term: Secondary hypertensionSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-004411-22-Outside-EU/EEA
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 200
- Successful completion of study CSPP100A2365E1
- Patients must meet inclusion criteria set forth for trials CSPP100A2365 and CSPP100A2365E1
- Informed consent/ patient assent
Are the trial subjects under 18? yes
Number of subjects for this age range: 200
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
- Patients who did not successfully complete studies CSPP100A2365 and CSPP100A2365E1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To evaluate the long term growth and development of pediatric hypertensive patients aged 6 – 17 years when treated previously with aliskiren;Secondary Objective: NA;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA
- Secondary Outcome Measures
Name Time Method Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA