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NCT00435162 · ClinicalTrials.gov registry record · Phase 3

Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
74
Enrollment target

NCT00435162: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.

NCT00435162 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 74 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00435162, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
74 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure \[SSBP\] ≥ 95th percentile ).

Interventions

  • DRUG Valsartan 0.25 mg/kg
  • DRUG Valsartan 1.0 mg/kg
  • DRUG Valsartan 4.0 mg/kg

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2007-03
Est. Completion 2009-01
Phase Phase 3
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT00435162 record still lists

NCT00435162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 3 interventions - of which Valsartan 0.25 mg/kg is the first listed.

NCT00435162 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00435162 about?

NCT00435162 is a clinical study titled "Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure". The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressu...

What is the current status of trial NCT00435162?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 74 participants. The study started on 2007-03. Estimated completion is 2009-01.

What interventions are being tested in trial NCT00435162?

The interventions under investigation include: Valsartan 0.25 mg/kg (DRUG), Valsartan 1.0 mg/kg (DRUG), Valsartan 4.0 mg/kg (DRUG).

Who is sponsoring clinical trial NCT00435162?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00435162's enrollment target sits among peer trials

74 1780th of 2000 higher than 221 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00435162, the US trial registry maintained by the National Library of Medicine. NCT00435162 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.