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NCT00853957 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension
A Phase 4 study of Hypertension, sponsored by Novartis.
- Completed
- Registry status
- Phase 4
- Development phase
- 443
- Enrollment target
- 9
- Study locations
NCT00853957: Completed Phase 4 study of Hypertension, sponsored by Novartis.
NCT00853957 is a Phase 4 study of Hypertension that has completed, run by Novartis. The registered enrollment target is 443 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 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00853957, a Phase 4 study of Hypertension, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 443 participants
- Enrollment target
- 9
- Study locations
Study Summary
The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension.
Primary Outcome
To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension.
Conditions Studied
Interventions
- DRUG Amlodipine
- DRUG Aliskiren/Amlodipine
Study Locations (9)
Maryland
- Investigative Site - Baltimore
- Investigative Site - Oxon Hill
New York
- Investigative Site - Brooklyn
- Investigative Site - Springfield Gardens
Illinois
- Investigative Site - Chicago
Michigan
- Investigative Site - Detroit
New Jersey
- Investigative Site - Trenton
Pennsylvania
- Investigative Site - Philadelphia
Wisconsin
- Investigative Site - Milwaukeee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 443 participants |
| Start Date | 2009-02 |
| Est. Completion | 2009-08 |
| Phase | Phase 4 |
What the finished NCT00853957 record still lists
NCT00853957 is an interventional study that assigns participants to a tested intervention. The registered 443 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 1 condition, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Amlodipine is the first listed.
NCT00853957 lists 9 locations in 7 states (Maryland, New York, Illinois).
Frequently Asked Questions
What is clinical trial NCT00853957 about?
NCT00853957 is a clinical study titled "Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension". The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension.
What is the current status of trial NCT00853957?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 443 participants. The study started on 2009-02. Estimated completion is 2009-08.
What conditions does trial NCT00853957 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT00853957?
The interventions under investigation include: Amlodipine (DRUG), Aliskiren/Amlodipine (DRUG).
Who is sponsoring clinical trial NCT00853957?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00853957 being conducted?
This trial has 9 study locations across Illinois, Maryland, Michigan, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT00853957's enrollment target sits among peer trials
443 139th of 470 higher than 332 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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