NCT01420068 is a clinical trial of SPP100 in Hypertension, sponsored by Noden Pharma.

Who is sponsoring NCT01420068?

NCT01420068 is sponsored by Noden Pharma.

What drugs are being tested in NCT01420068?

Interventions in NCT01420068: SPP100.

What condition does NCT01420068 study?

NCT01420068 studies Hypertension.

Is NCT01420068 still recruiting?

NCT01420068 is currently completed. Last updated 19 March 2019.

Are results published for NCT01420068?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-03-19 · How we verify

NCT01420068

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Results posted Last updated 19 March 2019

What this trial tests

trial testing SPP100 in Hypertension in 106 participants. Completed in 3 August 2017.

Timeline

19 August 2011

Primary endpoint
3 August 2017

3 August 2017

Quick facts

Lead sponsor	Noden Pharma
Status	Completed
Study type	OBSERVATIONAL
Enrollment	106
Start date	19 August 2011
Primary completion	3 August 2017
Estimated completion	3 August 2017
Sites	25 locations across Slovakia, Poland, Hungary, Puerto Rico, Guatemala, United States, Turkey (Türkiye)

Drugs / interventions tested

SPP100 — full drug profile →

Conditions studied

Hypertension — all drugs for Hypertension →

Sponsor

Noden Pharma — full company profile →

Who can join

Adults 6 to 17, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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) Primary · 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.

Group	Value	95% CI
Enalapril	8.90	± 1.359
Aliskiren	9.22	± 1.399

Change in Height Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS Primary · 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).

Group	Value	95% CI
Enalapril	7.27	± 0.586
Aliskiren	7.96	± 0.607

Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS Primary · 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.

Group	Value	95% CI
Enalapril	1.53	± 0.487
Aliskiren	1.56	± 0.502

Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS Primary · 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

Numbers: Forward raw score

Group	Value	95% CI
Enalapril	8
Aliskiren	4
Enalapril	0
Aliskiren	1
Enalapril	0
Aliskiren	1

Numbers: Backward raw score

Group	Value	95% CI
Enalapril	5
Aliskiren	4
Enalapril	2
Aliskiren	1
Enalapril	1
Aliskiren	1

Visual matching: Number correct

Group	Value	95% CI
Enalapril	7
Aliskiren	6
Enalapril	0
Aliskiren	0
Enalapril	1
Aliskiren	0

Visual matching: Time to complete (sec)

Group	Value	95% CI
Enalapril	0
Aliskiren	0
Enalapril	7
Aliskiren	6
Enalapril	1
Aliskiren	0

Sequences: Total raw score

Group	Value	95% CI
Enalapril	6
Aliskiren	6
Enalapril	1
Aliskiren	0
Enalapril	1
Aliskiren	0

Time tapping: Right hand

Group	Value	95% CI
Enalapril	7
Aliskiren	3
Enalapril	0
Aliskiren	0
Enalapril	1
Aliskiren	3

Time tapping: Left hand

Group	Value	95% CI
Enalapril	4
Aliskiren	2
Enalapril	3
Aliskiren	2
Enalapril	1
Aliskiren	2

Timed gait: Number of seconds

Group	Value	95% CI
Enalapril	4
Aliskiren	3
Enalapril	3
Aliskiren	0
Enalapril	1
Aliskiren	2

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

Primary Hypertension Group

Group	Value	95% CI
Enalapril	8.31	± 1.195
Aliskiren	8.33	± 1.182

Secondary Hypertension Group

Group	Value	95% CI
Enalapril	-0.73	± 3.699
Aliskiren	-3.80	± 3.445

Change in Height Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group Secondary · 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.

Primary Hypertension Group

Group	Value	95% CI
Enalapril	6.80	± 0.529
Aliskiren	7.42	± 0.528

Secondary Hypertension Group

Group	Value	95% CI
Enalapril	16.05	± 3.316
Aliskiren	16.96	± 3.044

Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group Secondary · 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.

Primary Hypertension Group

Group	Value	95% CI
Enalapril	1.30	± 0.428
Aliskiren	1.19	± 0.424

Secondary Hypertension Group

Group	Value	95% CI
Enalapril	-1.81	± 1.336
Aliskiren	-2.97	± 1.397

Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group Secondary · Baseline to EOS (3 years). EOS was defined as LT Visit 19 (Week 156) for participants with secondary hypertension.

Numbers: Forward raw score

Group	Value	95% CI
Enalapril	7
Aliskiren	5
Enalapril	1
Aliskiren	0
Enalapril	0
Aliskiren	1

Numbers: Backward raw score

Group	Value	95% CI
Enalapril	5
Aliskiren	4
Enalapril	2
Aliskiren	1
Enalapril	1
Aliskiren	1

Visual matching: Number correct

Group	Value	95% CI
Enalapril	6
Aliskiren	6
Enalapril	0
Aliskiren	0
Enalapril	2
Aliskiren	0

Visual matching: Time to complete (sec)

Group	Value	95% CI
Enalapril	0
Aliskiren	0
Enalapril	7
Aliskiren	6
Enalapril	1
Aliskiren	0

Sequences: Total raw score

Group	Value	95% CI
Enalapril	8
Aliskiren	6
Enalapril	0
Aliskiren	0
Enalapril	0
Aliskiren	0

Time tapping: Right hand

Group	Value	95% CI
Enalapril	5
Aliskiren	1
Enalapril	2
Aliskiren	1
Enalapril	1
Aliskiren	4

Time tapping: Left hand

Group	Value	95% CI
Enalapril	2
Aliskiren	2
Enalapril	3
Aliskiren	1
Enalapril	3
Aliskiren	3

Timed gait: Number of seconds

Group	Value	95% CI
Enalapril	4
Aliskiren	3
Enalapril	2
Aliskiren	0
Enalapril	2
Aliskiren	3

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Enalapril

Serious: 1/51 (2%)

Deaths: 0/51

Aliskiren

Serious: 0/55 (0%)

Deaths: 0/55

Serious adverse events (1 terms)

Reaction	System	Enalapril	Aliskiren
Phimosis	Congenital, familial and genetic disorders	—	—

Most-reported serious reactions: Phimosis.

Data from ClinicalTrials.gov NCT01420068 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Hypertension

Currently open trials in the same condition.

NCT07413159 — The "Check, Monitor, Control Hypertension" Study is a 24-month Randomized Trial in Houston Targeting African Americans A · NA · recruiting
NCT07361276 — Observational Study That Will Evaluate Treatment Patterns in the Management of Hypertension in the Public Primary Care S · recruiting
NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
NCT07238400 — Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia · Phase 2 · recruiting
NCT07135505 — Early Time-Restricted Eating in Older Adults With Hypertension · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01420068 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Noden Pharma
Last refreshed: 19 March 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01420068.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01420068

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Hypertension

Verify against primary sources