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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 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.

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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.

Conditions Studied

Hypertension

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

FieldValue
Enrollment Target 39 participants
Start Date 2009-04
Est. Completion 2010-01
Phase Phase 1

Sponsor

Novartis

265 total trials

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What the Registry Record Tells You About NCT00834041

The ClinicalTrials.gov registry entry for NCT00834041 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower). The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.

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 reports 5 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.