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52-104 Week Off-therapy Second Extension to Study CSPP100A2365

NCT ID: NCT01420068

Last Updated: 2019-03-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-19

Study Completion Date

2017-08-03

Brief Summary

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52-104 week off-therapy second extension to study CSPP100A2365 to assess growth and development in pediatric hypertensive patients previously treated with aliskiren in studies SPP100A2365 and SPP100A2365E1

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A Long Term Study of SPP100 in Patients With Essential Hypertension (Trial is Not Recruiting in the US)

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Detailed Description

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Conditions

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Hypertension

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

All patients previously treated with study medication in the CSPP100A2365 and CSPP100A2365E1 studies.

SPP100

Intervention Type DRUG

Interventions

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SPP100

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Successful completion of study CSPP100A2365E1
* Informed consent/ patient assent

Exclusion Criteria

•Patients who did not successfully complete studies CSPP100A2365 and CSPP100A2365E1
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Noden Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Birmingham, Alabama, United States

Site Status

Novartis Investigative Site

Little Rock, Arkansas, United States

Site Status

Novartis Investigative Site

Dalton, Georgia, United States

Site Status

Novartis Investigative Site

Lewiston, Idaho, United States

Site Status

Novartis Investigative Site

Hattiesburg, Mississippi, United States

Site Status

Novartis Investigative Site

Jackson, Mississippi, United States

Site Status

Novartis Investigative Site

New York, New York, United States

Site Status

Novartis Investigative Site

Portland, Oregon, United States

Site Status

Novartis Investigative Site

Portland, Oregon, United States

Site Status

Novartis Investigative Site

Charleston, South Carolina, United States

Site Status

Novartis Investigative Site

Amarillo, Texas, United States

Site Status

Novartis Investigative Site

Guatemala City, , Guatemala

Site Status

Novartis Investigative Site

Budapest, , Hungary

Site Status

Novartis Investigative Site

Nyíregyháza, , Hungary

Site Status

Novartis Investigative Site

Szeged, , Hungary

Site Status

Novartis Investigative Site

Veszprém, , Hungary

Site Status

Novartis Investigative Site

Warsaw, , Poland

Site Status

Novartis Investigative Site

San Juan, , Puerto Rico

Site Status

Novartis Investigative Site

Bratislava, , Slovakia

Site Status

Novartis Investigative Site

Martin, , Slovakia

Site Status

Novartis Investigative Site

Myjava, , Slovakia

Site Status

Novartis Investigative Site

Prešov, , Slovakia

Site Status

Novartis Investigative Site

Trnava, , Slovakia

Site Status

Novartis Investigative Site

Ankara, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Ankara, , Turkey (Türkiye)

Site Status

Countries

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United States Guatemala Hungary Poland Puerto Rico Slovakia Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2011-004411-22

Identifier Type: -

Identifier Source: secondary_id

CSPP100A2365E2

Identifier Type: -

Identifier Source: org_study_id

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