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NCT00219141 · ClinicalTrials.gov registry record · Phase 3
Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension
A Phase 3 study of Hypertension and Overweight, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 460
- Enrollment target
- 9
- Study locations
NCT00219141: Completed Phase 3 study of Hypertension and Overweight, sponsored by Novartis Pharmaceuticals.
NCT00219141 is a Phase 3 study of Hypertension and Overweight that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 460 participants, below the 3,506-participant average among 470 other Hypertension trials with a reported enrollment target (87% lower). The trial reports 9 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00219141, a Phase 3 study of Hypertension and Overweight, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 460 participants
- Enrollment target
- 9
- Study locations
Study Summary
To compare the efficacy and safety of aliskiren in combination with losartan compared to losartan on the regression of the increased size of the left ventricle in overweight patients with high blood pressure.
Primary Outcome
Left ventricular mass index (LVMI) was measured by magnetic resonance imaging (MRI). An increase in LVMI indicates hypertrophy of the left ventricle. This could be a normal reversible response to cardiovascular conditioning (athletic heart) or an abnormal irreversible response to chronically increased volume load (preload) or increased pressure load (afterload). Thickening of the ventricular muscle results in increased left ventricular pressure, increased end-systolic volume, and decreased end-d
Conditions Studied
Interventions
- DRUG Aliskiren 150/300 mg
- DRUG Losartan 50/100 mg
- DRUG Aliskiren placebo
- DRUG Losartan 50/100 mg placebo
Study Locations (9)
Other
- sites in Argentina - Argentina
- sites in Colombia - Colombia
- sites in Finland - Finland
- sites in Germany - Germany
- sites in Italy - Italy
- sites in Russia - Russia
- sites in Spain - Spain
- sites in Sweden - Sweden
New Jersey
- Novartis Pharmaceuticals - East Hanover
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2005-10 |
| Est. Completion | 2007-11 |
| Phase | Phase 3 |
What the finished NCT00219141 record still lists
NCT00219141 is an interventional study that assigns participants to a tested intervention. The registered 460 participants enrollment target is mid-sized for trials with a published cap, below the 3,506-participant average among 470 other Hypertension trials with a reported enrollment target (87% lower).
The record links to 3 conditions, with Hypertension appearing as the primary indexed condition, and to 4 interventions - of which Aliskiren 150/300 mg is the first listed.
NCT00219141 lists 9 locations in 2 states (Other, New Jersey).
Frequently Asked Questions
What is clinical trial NCT00219141 about?
NCT00219141 is a clinical study titled "Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension". To compare the efficacy and safety of aliskiren in combination with losartan compared to losartan on the regression of the increased size of the left ventricle in overweight patients with high blood pressure.
What is the current status of trial NCT00219141?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 460 participants. The study started on 2005-10. Estimated completion is 2007-11.
What conditions does trial NCT00219141 study?
This clinical trial studies the following conditions: Hypertension, Overweight, Left Ventricular Hypertrophy.
What interventions are being tested in trial NCT00219141?
The interventions under investigation include: Aliskiren 150/300 mg (DRUG), Losartan 50/100 mg (DRUG), Aliskiren placebo (DRUG), Losartan 50/100 mg placebo (DRUG).
Who is sponsoring clinical trial NCT00219141?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00219141 being conducted?
This trial has 9 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00219141's enrollment target sits among peer trials
460 133rd of 470 higher than 338 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension 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.
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