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Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus
NCT00927394 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00927394
The ClinicalTrials.gov registry entry for NCT00927394 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 60 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00927394 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Delaware, Missouri, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00927394?
This trial is sponsored by Novartis, which has 60 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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