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COMPLETED Phase 4

Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension

NCT00853957 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 443 participants
Start Date 2009-02
Est. Completion 2009-08
Phase Phase 4

Sponsor

Novartis

60 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00853957

The ClinicalTrials.gov registry entry for NCT00853957 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 443 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 2 interventions — of which Amlodipine 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: NCT00853957 reports 9 study locations spanning 7 distinct geographic areas — top geographies include Maryland, New York, Illinois. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00853957?

The interventions under investigation include: Amlodipine (DRUG), Aliskiren/Amlodipine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00853957?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial