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NCT00927394 · ClinicalTrials.gov registry record · Phase 4
Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus
A Phase 4 study of Hypertension, sponsored by Novartis.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,143
- Enrollment target
- 4
- Study locations
NCT00927394: Completed Phase 4 study of Hypertension, sponsored by Novartis.
NCT00927394 is a Phase 4 study of Hypertension that has completed, run by Novartis. The registered enrollment target is 1,143 participants, below the 3,505-participant average among 470 other Hypertension trials with a reported enrollment target (67% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00927394, a Phase 4 study of Hypertension, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,143 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of the study was to evaluate the blood pressure (BP)-lowering efficacy of the combination of aliskiren and valsartan, as initial therapy, compared to valsartan monotherapy in Type II Diabetic patients with Stage II hypertension.
Primary Outcome
The 24-hour ambulatory systolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly systolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MASBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24.
Conditions Studied
Interventions
- DRUG Valsartan
- DRUG Aliskiren
- DRUG Placebo for Aliskiren
- DRUG Placebo for Valsartan
Study Locations (4)
Delaware
- Investigative Site - Newark
Missouri
- Investigative Site - Kansas City
New Jersey
- Investigative Site - Camden
Pennsylvania
- Investigative Site - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,143 participants |
| Start Date | 2009-05 |
| Est. Completion | 2011-10 |
| Phase | Phase 4 |
What the finished NCT00927394 record still lists
NCT00927394 is an interventional study that assigns participants to a tested intervention. Its 1,143 participants enrollment target places it among the larger protocols in the corpus, below the 3,505-participant average among 470 other Hypertension trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 4 interventions - of which Valsartan is the first listed.
NCT00927394 reports a single indexed study location in Delaware, Missouri, New Jersey.
Frequently Asked Questions
What is clinical trial NCT00927394 about?
NCT00927394 is a clinical study titled "Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus". The purpose of the study was to evaluate the blood pressure (BP)-lowering efficacy of the combination of aliskiren and valsartan, as initial therapy, compared to valsartan monotherapy in Type II Diabetic patients with Stage II hypertension.
What is the current status of trial NCT00927394?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,143 participants. The study started on 2009-05. Estimated completion is 2011-10.
What conditions does trial NCT00927394 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT00927394?
The interventions under investigation include: Valsartan (DRUG), Aliskiren (DRUG), Placebo for Aliskiren (DRUG), Placebo for Valsartan (DRUG).
Who is sponsoring clinical trial NCT00927394?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00927394 being conducted?
This trial has 4 study locations across Delaware, Missouri, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT00927394's enrollment target sits among peer trials
1,143 60th of 470 higher than 411 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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