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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 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 74 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2007-03 |
| Est. Completion | 2009-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00435162
The ClinicalTrials.gov registry entry for NCT00435162 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Valsartan 0.25 mg/kg is the first listed.
NCT00435162 reports 0 study locations.
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.
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