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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
Hypertension
MedDRA version: 14.1Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.1Level: PTClassification code 10039834Term: Secondary hypertensionSystem Organ Class: 10047065 - Vascular disorders
Therapeutic 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
Inclusion Criteria

- 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

Exclusion Criteria

- 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
NameTimeMethod
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
NameTimeMethod
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA
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