Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01150357 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 267 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
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 |
What the finished NCT01150357 record still lists
NCT01150357 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Aliskiren (6.25/12.5/25 mg) is the first listed.
NCT01150357 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01150357's enrollment target sits among peer trials
267 1222nd of 2000 higher than 779 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04997109 · 267 participants · NA
Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy
- NCT05355701 · 267 participants · Phase 1
A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.
- NCT06203509 · 267 participants · NA
Improving Care Transitions for Medicaid Insured Individuals With Co-occurring Serious Mental Illness
- NCT05000632 · 268 participants · NA
Smoke Free SafeCare: Establishing a Smoke Free Home in CPS-involved Families
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia