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NCT01150357 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 267
- Enrollment target
NCT01150357 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 267 participants.
The verdict
NCT01150357, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 267 participants
- Enrollment target
Study Summary
This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600 mg of aliskiren. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in children 6-17 years of age.
Interventions
- DRUG Aliskiren (6.25/12.5/25 mg)
- DRUG Aliskiren (37.5/75/150 mg)
- DRUG Aliskiren (150/300/600 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01150357
The ClinicalTrials.gov registry entry for NCT01150357 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 267 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 Aliskiren (6.25/12.5/25 mg) is the first listed.
NCT01150357 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01150357 about?
NCT01150357 is a clinical study titled "Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age". This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 ...
What is the current status of trial NCT01150357?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 267 participants. The study started on 2010-06. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01150357?
The interventions under investigation include: Aliskiren (6.25/12.5/25 mg) (DRUG), Aliskiren (37.5/75/150 mg) (DRUG), Aliskiren (150/300/600 mg) (DRUG).
Who is sponsoring clinical trial NCT01150357?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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