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

March 7, 2019 updated by: Noden Pharma

A Multicenter, Double-blind 52 to 104 Week Off-therapy Extension Study to Evaluate the Long Term Growth and Development of Pediatric Hypertensive Patients 6 - 17 Years of Age Previously Treated With Aliskiren in Studies CSPP100A2365 and/or CSPP100A2365E1

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guatemala
      • Guatemala City, Guatemala, 01010
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1131
        • Novartis Investigative Site
      • Nyiregyhaza, Hungary, 4400
        • Novartis Investigative Site
      • Szeged, Hungary, 6725
        • Novartis Investigative Site
      • Veszprem, Hungary, H-8200
        • Novartis Investigative Site
  • Poland
      • Warsaw, Poland, 03 - 335
        • Novartis Investigative Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00907
        • Novartis Investigative Site
  • Slovakia
      • Bratislava, Slovakia, 85107
        • Novartis Investigative Site
      • Martin, Slovakia, 03601
        • Novartis Investigative Site
      • Myjava, Slovakia, 90701
        • Novartis Investigative Site
      • Presov, Slovakia, 08001
        • Novartis Investigative Site
      • Trnava, Slovakia, 91701
        • Novartis Investigative Site
  • Turkey
      • Ankara, Turkey, 06500
        • Novartis Investigative Site
      • Ankara, Turkey, 06490
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0006
        • Novartis Investigative Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Novartis Investigative Site
    • Georgia
      • Dalton, Georgia, United States, 30721
        • Novartis Investigative Site
    • Idaho
      • Lewiston, Idaho, United States, 83501
        • Novartis Investigative Site
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Novartis Investigative Site
      • Jackson, Mississippi, United States, 39209
        • Novartis Investigative Site
    • New York
      • New York, New York, United States, 10016
        • Novartis Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97225
        • Novartis Investigative Site
      • Portland, Oregon, United States, 07227
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Novartis Investigative Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

pediatric hypertensive patients 6 - 17 years of age previously treated with aliskiren in studies CSPP100A2365 and/or CSPP100A2365E1

Description

Inclusion Criteria:

  • Successful completion of study CSPP100A2365E1
  • Patients must meet inclusion criteria set forth for trials CSPP100A2365 and CSPP100A2365E1
  • Informed consent/ patient assent

Exclusion Criteria:

•Patients who did not successfully complete studies CSPP100A2365 and CSPP100A2365E1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
All patients
All patients previously treated with study medication in the CSPP100A2365 and CSPP100A2365E1 studies.
Drug: SPP100

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Weight Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the Enrolled to Follow-up Set (EFS)
Time Frame: Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)
Participant weight was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension). Body weight was measured to the nearest 0.1 kg in indoor clothing, but without shoes.
Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)
Change in Height Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS
Time Frame: Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)
Participant height was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension).
Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)
Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS
Time Frame: Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)
Participant height and weight was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension). BMI was derived.
Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)
Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS
Time Frame: Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)
All participants who were determined to have secondary hypertension in the core study and had a Baseline (Visit 2) standardized neurocognitive assessment in the core study received follow-up neurocognitive assessments at LT Visit 18 and LT Visit 19 with the same tool. The neurocognitive assessment of development included assessment of the following abilities: Attention, Processing speed, Working memory, and Motor speed. For Numbers (Forward and Backward Raw Score), Visual Matching (Number Correct), Sequences (Total Raw Score): positive change indicates a numerical increase, which is considered a better outcome/improvement; negative change/numerical decrease is considered a worse outcome/decline. For Visual Matching (Time to Complete), Time Tapping (Right and Left Hands), and Timed Gait: positive change indicates a numerical increase, which is considered a worse outcome/decline; negative change/numerical decrease is considered a better outcome/improvement.
Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Weight Assessments From Baseline (Visit 2 of the Core Study) to End of Study (EOS) by Hypertension Group
Time Frame: Baseline to EOS (2 to 3 years). EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.
Participant weight was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension). Body weight was measured to the nearest 0.1 kg in indoor clothing, but without shoes.
Baseline to EOS (2 to 3 years). EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.
Change in Height Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group
Time Frame: Baseline to EOS (2 to 3 years). EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.
Participant height was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension).
Baseline to EOS (2 to 3 years). EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.
Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group
Time Frame: Baseline to EOS (2 to 3 years). EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.
Participant weight and height was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension). Body weight was measured to the nearest 0.1 kg in indoor clothing, but without shoes. BMI was derived.
Baseline to EOS (2 to 3 years). EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.
Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group
Time Frame: Baseline to EOS (3 years). EOS was defined as LT Visit 19 (Week 156) for participants with secondary hypertension.
All participants who were determined to have secondary hypertension in the core study and had a Baseline (Visit 2) standardized neurocognitive assessment in the core study received follow-up neurocognitive assessments at LT Visit 18 and LT Visit 19 with the same tool. The neurocognitive assessment of development included assessment of the following abilities: Attention, Processing speed, Working memory, and Motor speed. For Numbers (Forward and Backward Raw Score), Visual Matching (Number Correct), Sequences (Total Raw Score): positive change indicates a numerical increase, which is considered a better outcome/improvement; negative change/numerical decrease is considered a worse outcome/decline. For Visual Matching (Time to Complete), Time Tapping (Right and Left Hands), and Timed Gait: positive change indicates a numerical increase, which is considered a worse outcome/decline; negative change/numerical decrease is considered a better outcome/improvement.
Baseline to EOS (3 years). EOS was defined as LT Visit 19 (Week 156) for participants with secondary hypertension.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Noden Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 3, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 3, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSPP100A2365E2
  • 2011-004411-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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