NCT01420068

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
7 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

August 19, 2011

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2017

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 15, 2019

Completed
Last Updated

March 19, 2019

Status Verified

September 1, 2018

Enrollment Period

6 years

First QC Date

August 17, 2011

Results QC Date

September 11, 2018

Last Update Submit

March 7, 2019

Conditions

Hypertension

Keywords

Pediatrichypertensionaliskiren

Outcome Measures

Primary Outcomes (4)

  • 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)

    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

    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

    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

    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 Outcomes (4)

  • Change in Weight Assessments From Baseline (Visit 2 of the Core Study) to End of Study (EOS) by Hypertension Group

    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

    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

    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

    Baseline to EOS (3 years). EOS was defined as LT Visit 19 (Week 156) for participants with secondary hypertension.

Study Arms (1)

All patients

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

Drug: SPP100

Interventions

SPP100DRUG
All patients

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients who did not successfully complete studies CSPP100A2365 and CSPP100A2365E1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Novartis Investigative Site

Birmingham, Alabama, 35294-0006, United States

Location

Novartis Investigative Site

Little Rock, Arkansas, 72202, United States

Location

Novartis Investigative Site

Dalton, Georgia, 30721, United States

Location

Novartis Investigative Site

Lewiston, Idaho, 83501, United States

Location

Novartis Investigative Site

Hattiesburg, Mississippi, 39401, United States

Location

Novartis Investigative Site

Jackson, Mississippi, 39209, United States

Location

Novartis Investigative Site

New York, New York, 10016, United States

Location

Novartis Investigative Site

Portland, Oregon, 07227, United States

Location

Novartis Investigative Site

Portland, Oregon, 97225, United States

Location

Novartis Investigative Site

Charleston, South Carolina, 29425, United States

Location

Novartis Investigative Site

Amarillo, Texas, 79106, United States

Location

Novartis Investigative Site

Guatemala City, 01010, Guatemala

Location

Novartis Investigative Site

Budapest, 1131, Hungary

Location

Novartis Investigative Site

Nyíregyháza, 4400, Hungary

Location

Novartis Investigative Site

Szeged, 6725, Hungary

Location

Novartis Investigative Site

Veszprém, H-8200, Hungary

Location

Novartis Investigative Site

Warsaw, 03 - 335, Poland

Location

Novartis Investigative Site

San Juan, 00907, Puerto Rico

Location

Novartis Investigative Site

Bratislava, 85107, Slovakia

Location

Novartis Investigative Site

Martin, 03601, Slovakia

Location

Novartis Investigative Site

Myjava, 90701, Slovakia

Location

Novartis Investigative Site

Prešov, 08001, Slovakia

Location

Novartis Investigative Site

Trnava, 91701, Slovakia

Location

Novartis Investigative Site

Ankara, 06490, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, 06500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Limitations and Caveats

Due to small sample sizes in the secondary hypertension etiology subgroups, the corresponding p-values for treatment comparisons should be interpreted with caution.

Results Point of Contact

Title
Ciara Walsh
Organization
Noden Pharma DAC
cwalsh@nodenpharma.com
+ 353 1 9121573

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2011

First Posted

August 19, 2011

Study Start

August 19, 2011

Primary Completion

August 3, 2017

Study Completion

August 3, 2017

Last Updated

March 19, 2019

Results First Posted

February 15, 2019

Record last verified: 2018-09

Locations

PL(1)GU(1)TU(2)HU(4)SL(5)US(11)PR(1)