An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age
Public ClinicalTrials.gov record NCT01151410. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Double-blind, Randomized, 52-week, Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term safety, tolerability and efficacy profile of aliskiren compared to the active comparator enalapril in children, 6 - 17 years old with hypertension (msSBP ≥ 95th percentile for age, gender and height, at baseline in study CSPP100A2365). Patients will be randomized to receive either aliskiren or enalapril. Weight-group based doses of aliskiren or enalapril will be administered once daily and children will receive study medication in a double-blind manner. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in pediatric patients 6-17 years of age (age at baseline in Study CSPP100A2365).
Study identification
- NCT ID
- NCT01151410
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 208 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2010
- Primary completion
- Jul 31, 2015
- Completion
- Jul 31, 2015
- Last update posted
- Mar 6, 2016
2010 – 2015
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35294-0006 | — |
| Novartis Investigative Site | Little Rock | Arkansas | 72202 | — |
| Novartis Investigative Site | Los Angeles | California | 90048 | — |
| Novartis Investigative Site | Dalton | Georgia | 30721 | — |
| Novartis Investigative Site | Lewiston | Idaho | 83501 | — |
| Novartis Investigative Site | Park Ridge | Illinois | 60068 | — |
| Novartis Investigative Site | Louisville | Kentucky | 40202 | — |
| Novartis Investigative Site | Hattiesburg | Mississippi | 39401 | — |
| Novartis Investigative Site | Jackson | Mississippi | 39209 | — |
| Novartis Investigative Site | New York | New York | 10016 | — |
| Novartis Investigative Site | Columbus | Ohio | 43205 | — |
| Novartis Investigative Site | Toledo | Ohio | 43606 | — |
| Novartis Investigative Site | Portland | Oregon | 07227 | — |
| Novartis Investigative Site | Portland | Oregon | 97225 | — |
| Novartis Investigative Site | Charleston | South Carolina | 29425 | — |
| Novartis Investigative Site | Amarillo | Texas | 79106 | — |
| Novartis Investigative Site | Charleston | West Virginia | 25304 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01151410, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 6, 2016 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01151410 live on ClinicalTrials.gov.