HypertensionNCT01420068

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

An observational study of Hypertension, run by LXO Group at 25 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Hypertension
What is being tested?: SPP100
How many people: 106 participants
Where: 25 sitesin 7 countries
Study dates: 19 Aug 2011to 3 Aug 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 17 years
All sexes
No healthy volunteers
Child

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

Who may be able to join

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

Who cannot join

•Patients who did not successfully complete studies CSPP100A2365 and CSPP100A2365E1

Trial locations and contacts

25 sites in 7 countries.

Country

City, postcode or hospital

25 sites in 7 countries

United States11 sites

Novartis Investigative Site
Amarillo, Texas, 79106
Novartis Investigative Site
Birmingham, Alabama, 35294-0006
Novartis Investigative Site
Charleston, South Carolina, 29425
Novartis Investigative Site
Dalton, Georgia, 30721
Novartis Investigative Site
Hattiesburg, Mississippi, 39401
Novartis Investigative Site
Jackson, Mississippi, 39209
Novartis Investigative Site
Lewiston, Idaho, 83501
Novartis Investigative Site
Little Rock, Arkansas, 72202
Novartis Investigative Site
New York, New York, 10016
Novartis Investigative Site
Portland, Oregon, 07227
Novartis Investigative Site
Portland, Oregon, 97225

Other trials in United States

Slovakia5 sites

Novartis Investigative Site
Bratislava, 85107
Novartis Investigative Site
Martin, 03601
Novartis Investigative Site
Myjava, 90701
Novartis Investigative Site
Prešov, 08001
Novartis Investigative Site
Trnava, 91701

Other trials in Slovakia

Hungary4 sites

Novartis Investigative Site
Budapest, 1131
Novartis Investigative Site
Nyíregyháza, 4400
Novartis Investigative Site
Szeged, 6725
Novartis Investigative Site
Veszprém, H-8200

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Turkey (Türkiye)2 sites

Novartis Investigative Site
Ankara, 06490
Novartis Investigative Site
Ankara, 06500

Other trials in Turkey (Türkiye)

Guatemala1 site

Novartis Investigative Site
Guatemala City, 01010

Other trials in Guatemala

Poland1 site

Novartis Investigative Site
Warsaw, 03 - 335

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Puerto Rico1 site

Novartis Investigative Site
San Juan, 00907

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About this study

Official title: 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

Conditions: Hypertension
Being tested: SPP100
Keywords: Pediatric, hypertension, aliskiren
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SPP100Drug

Study groups in NCT01420068
Study group	Role	What they receive
All patients		All patients previously treated with study medication in the CSPP100A2365 and CSPP100A2365E1 studies. Receives: Drug: SPP100

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Aug 20113 Aug 2017

First posted19 Aug 2011 (estimated)
Study start19 Aug 2011
Primary completion3 Aug 2017
Study completion3 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01420068
Sponsor's protocol ID: CSPP100A2365E2
Other IDs: 2011-004411-22
Status last verified: Sep 2018
First submitted: 17 Aug 2011
Last updated: 19 Mar 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01420068
Acronym / sponsor ID: CSPP100A2365E2
Conditions: Hypertension
Keywords: Pediatric, hypertension, aliskiren
Study type: Observational
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: LXO GroupIndustry (pharma, biotech, devices)
Study start: 19 Aug 2011 (actual)
Primary completion: 3 Aug 2017 (actual)
Study completion: 3 Aug 2017 (actual)
First posted: 19 Aug 2011 (estimated)
Results: Posted 15 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All patients	–	Drug: SPP100All patients previously treated with study medication in the CSPP100A2365 and CSPP100A2365E1 studies.

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: pediatric hypertensive patients 6 - 17 years of age previously treated with aliskiren in studies CSPP100A2365 and/or CSPP100A2365E1

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

•Patients who did not successfully complete studies CSPP100A2365 and CSPP100A2365E1

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SPP100	Drug	All patients

Primary outcome

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.
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).
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.
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.

4 secondary outcomes

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.
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.
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.
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.

Results and safety

Results posted to the registry on 15 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enalapril	51	49
Aliskiren	55	50

Primary outcome: 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). Least squares mean (Standard Error). Unit: kg

Measure	Enalapril n = 49	Aliskiren n = 50
Value	8.90 (1.359)	9.22 (1.399)

Enalapril vs Aliskiren: Mean Difference (Net): 0.31 (95% CI -2.74 to 3.37), p = 0.840, ANCOVA

Population analysed: The EFS consisted of all participants who signed the informed consent form (ICF) for the second extension study. Number of participants is the number of EFS participants with non-missing measurement at LT Visit 18. Participants with missing data at LT Visit 18 were not included in the analysis.

Primary outcome: 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). Least squares mean (Standard Error). Unit: cm

Measure	Enalapril n = 49	Aliskiren n = 50
Value	7.27 (0.586)	7.96 (0.607)

Enalapril vs Aliskiren: Mean Difference (Net): 0.69 (95% CI -0.63 to 2.02), p = 0.303, ANCOVA

Population analysed: The EFS consisted of all participants who signed the ICF for the second extension study. Number of participants is the number of EFS participants with non-missing measurement at LT Visit 18. Participants with missing data at LT Visit 18 were not included in the analysis.

Primary outcome: 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). Least squares mean (Standard Error). Unit: kg/m^2

Measure	Enalapril n = 49	Aliskiren n = 50
Value	1.53 (0.487)	1.56 (0.502)

Enalapril vs Aliskiren: Mean Difference (Net): 0.03 (95% CI -1.06 to 1.12), p = 0.957, ANCOVA

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Enalapril n = 8	Aliskiren n = 6
Numbers: Forward raw score: Positive change	8	4
Numbers: Forward raw score: No change	0	1
Numbers: Forward raw score: Negative change	0	1
Numbers: Backward raw score: Positive change	5	4
Numbers: Backward raw score: No change	2	1
Numbers: Backward raw score: Negative change	1	1
Visual matching: Number correct: Positive change	7	6
Visual matching: Number correct: No change	0	0

Population analysed: The EFS consisted of all participants who signed the ICF for the second extension study. Number of participants is those with secondary hypertension and both baseline and LT Visit 18 observations for that test.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: This study only collected the occurrence of Serious Adverse Events (SAEs) occurring within the first 30 days after the participant had completed the first extension study. SAEs experienced after this 30 day period were reported to Novartis/Noden only if the investigator suspected a causal relationship to the study drug. Every SAE, within the above timeframe was to be reported to Novartis/Noden within 24 hours of learning of its occurrence.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enalapril	1 of 51 (2%)	0 of 51 (0%)	0 of 51
Aliskiren	0 of 55 (0%)	0 of 55 (0%)	0 of 55

Limitations and caveats (from the sponsor): Due to small sample sizes in the secondary hypertension etiology subgroups, the corresponding p-values for treatment comparisons should be interpreted with caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

25 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by LXO Group at 25 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Slovakia, Hungary, Turkey (Türkiye), Guatemala and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01420068.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019; AzTrials last refreshed its copy on 29 Oct 2026.