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NCT00654875 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of Once Daily Dosing of Aliskiren (300 mg (qd) Once a Day) to Twice Daily Dosing of Aliskiren (150 mg (Bid) Twice a Day) in Treating Moderate Hypertension.
A Phase 4 study of Essential Hypertension, sponsored by Novartis.
- Completed
- Registry status
- Phase 4
- Development phase
- 328
- Enrollment target
- 3
- Study locations
NCT00654875: Completed Phase 4 study of Essential Hypertension, sponsored by Novartis.
NCT00654875 is a Phase 4 study of Essential Hypertension that has completed, run by Novartis. The registered enrollment target is 328 participants, below the 763-participant average among 8 other Essential Hypertension trials with a reported enrollment target (57% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00654875, a Phase 4 study of Essential Hypertension, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 328 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study will compare the safety and efficacy of once daily dosing of aliskiren to twice daily dosing of aliskiren in patients with moderate hypertension
Primary Outcome
An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MADBP from baseline to the 24 hour MADBP at 6 weeks was calculated using an Analysis of covariance (ANCOVA) model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate.
Conditions Studied
Interventions
- DRUG Aliskiren
- DRUG Placebo to Aliskiren
Study Locations (3)
Other
- Investigative Site - Frankfurt
- Investigative Site - Valencia
Ohio
- Investigative Site - Zanesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 328 participants |
| Start Date | 2008-03 |
| Est. Completion | 2008-11 |
| Phase | Phase 4 |
What the finished NCT00654875 record still lists
NCT00654875 is an interventional study that assigns participants to a tested intervention. The registered 328 participants enrollment target is mid-sized for trials with a published cap, below the 763-participant average among 8 other Essential Hypertension trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Essential Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Aliskiren is the first listed.
NCT00654875 reports a single indexed study location in Other, Ohio.
Frequently Asked Questions
What is clinical trial NCT00654875 about?
NCT00654875 is a clinical study titled "Efficacy and Safety of Once Daily Dosing of Aliskiren (300 mg (qd) Once a Day) to Twice Daily Dosing of Aliskiren (150 mg (Bid) Twice a Day) in Treating Moderate Hypertension.". This study will compare the safety and efficacy of once daily dosing of aliskiren to twice daily dosing of aliskiren in patients with moderate hypertension
What is the current status of trial NCT00654875?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 328 participants. The study started on 2008-03. Estimated completion is 2008-11.
What conditions does trial NCT00654875 study?
This clinical trial studies the following conditions: Essential Hypertension.
What interventions are being tested in trial NCT00654875?
The interventions under investigation include: Aliskiren (DRUG), Placebo to Aliskiren (DRUG).
Who is sponsoring clinical trial NCT00654875?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00654875 being conducted?
This trial has 3 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Essential Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00654875's enrollment target sits among peer trials
328 6th of 8 higher than 3 of 8 other Essential Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Essential 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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