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NCT01151410 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Hypertension, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 208
- Enrollment target
- 20
- Study locations
NCT01151410: Completed Phase 3 study of Hypertension, sponsored by Novartis Pharmaceuticals.
NCT01151410 is a Phase 3 study of Hypertension that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 208 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01151410, a Phase 3 study of Hypertension, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 208 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Conditions Studied
Interventions
- DRUG Aliskiren
- DRUG Enalapril
Study Locations (20)
Mississippi
- Novartis Investigative Site - Hattiesburg
- Novartis Investigative Site - Jackson
Ohio
- Novartis Investigative Site - Columbus
- Novartis Investigative Site - Toledo
Oregon
- Novartis Investigative Site - Portland
- Novartis Investigative Site - Portland
Hungary
- Novartis Investigative Site - Nyíregyháza
- Novartis Investigative Site - Szeged
Alabama
- Novartis Investigative Site - Birmingham
Arkansas
- Novartis Investigative Site - Little Rock
California
- Novartis Investigative Site - Los Angeles
Georgia
- Novartis Investigative Site - Dalton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2010-08 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
What the finished NCT01151410 record still lists
NCT01151410 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Aliskiren is the first listed.
NCT01151410 names 20 study sites across 16 states, led by Mississippi, Ohio, Oregon.
Frequently Asked Questions
What is clinical trial NCT01151410 about?
NCT01151410 is a clinical study titled "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". 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 bas...
What is the current status of trial NCT01151410?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 208 participants. The study started on 2010-08. Estimated completion is 2015-08.
What conditions does trial NCT01151410 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT01151410?
The interventions under investigation include: Aliskiren (DRUG), Enalapril (DRUG).
Who is sponsoring clinical trial NCT01151410?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01151410 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01151410's enrollment target sits among peer trials
208 214th of 470 higher than 256 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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