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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420068
• Other study ID #: CSPP100A2365E2
• Secondary ID: 2011-004411-22
• Status: Completed
• Start date: August 19, 2011
• Est. completion date: August 3, 2017

Study information

• Verified date: September 2018
• Source: Noden Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 3, 2017
• Est. primary completion date: August 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• SPP100

Locations

Country	Name	City	State
Guatemala	Novartis Investigative Site	Guatemala City
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Nyiregyhaza
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Veszprem
Poland	Novartis Investigative Site	Warsaw
Puerto Rico	Novartis Investigative Site	San Juan
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Martin
Slovakia	Novartis Investigative Site	Myjava
Slovakia	Novartis Investigative Site	Presov
Slovakia	Novartis Investigative Site	Trnava
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Ankara
United States	Novartis Investigative Site	Amarillo	Texas
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Dalton	Georgia
United States	Novartis Investigative Site	Hattiesburg	Mississippi
United States	Novartis Investigative Site	Jackson	Mississippi
United States	Novartis Investigative Site	Lewiston	Idaho
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Noden Pharma

Countries where clinical trial is conducted

United States,  Guatemala,  Hungary,  Poland,  Puerto Rico,  Slovakia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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.	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.
Secondary	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).	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.
Secondary	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.	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.
Secondary	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.	Baseline to EOS (3 years). EOS was defined as LT Visit 19 (Week 156) for participants with secondary hypertension.