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NCT00834041 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age
A Phase 1 study of Hypertension, sponsored by Novartis.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 5
- Study locations
NCT00834041: Completed Phase 1 study of Hypertension, sponsored by Novartis.
NCT00834041 is a Phase 1 study of Hypertension that has completed, run by Novartis. The registered enrollment target is 39 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00834041, a Phase 1 study of Hypertension, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 5
- Study locations
Study Summary
This first open-label study in a pediatric population was designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with hypertension.
Primary Outcome
Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.
Conditions Studied
Interventions
- DRUG Aliskiren 3.125 mini-tablets
Study Locations (5)
Other
- Investigative Site - Brussels
- Investigative Site - Brasília
- Investigative Site - Budapest
- Investigative Site - Warsaw
Kentucky
- Investigative Site - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2009-04 |
| Est. Completion | 2010-01 |
| Phase | Phase 1 |
What the finished NCT00834041 record still lists
NCT00834041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Aliskiren 3.125 mini-tablets is the first listed.
NCT00834041 lists 5 locations in 2 states (Other, Kentucky).
Frequently Asked Questions
What is clinical trial NCT00834041 about?
NCT00834041 is a clinical study titled "A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age". This first open-label study in a pediatric population was designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with hypertension.
What is the current status of trial NCT00834041?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2009-04. Estimated completion is 2010-01.
What conditions does trial NCT00834041 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT00834041?
The interventions under investigation include: Aliskiren 3.125 mini-tablets (DRUG).
Who is sponsoring clinical trial NCT00834041?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00834041 being conducted?
This trial has 5 study locations across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00834041's enrollment target sits among peer trials
39 392nd of 470 higher than 78 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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