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COMPLETED Phase 3

Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

NCT00643201 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

Conditions Studied

Interventions

  • DRUG Enoxaparin
  • DRUG warfarin
  • DRUG Placebo for apixaban
  • DRUG Placebo for enoxaparin
  • DRUG Placebo for warfarin

Study Locations (20)

California

  • Beaver Medical Group — Banning
  • University Of California San Francisco-Fresno — Fresno
  • University Of California, Davis Medical Center — Sacramento
  • Chest Medicine & Critical Care Medical Gr. Inc. — San Diego
  • Stanford University Medical Center — Stanford
  • Harbor Ucla Medical Center — Torrance

Florida

  • Bay Pines Va Healthcare Systems — Bay Pines
  • Daniel G. Lorch, Jr, Md, Cpi — Brandon
  • Research Alliance, Inc. — Clearwater
  • River City Clinical Research — Jacksonville
  • Pasadena Center For Medical Research — St. Petersburg

Alabama

  • Alabama Clinical Therapeutics, Llc — Birmingham
  • Horizon Research Group, Inc. — Mobile

Arkansas

  • Fort Smith Lung Center — Fort Smith
  • University Of Arkansas For Medical Sciences — Little Rock

Colorado

  • New West Physicians — Golden
  • Drogue Medical, Llc — Wheat Ridge

Connecticut

  • Bridgeport Hospital — Bridgeport
  • Dept Of Internal Med, Sect Of Pulmonary & Critical Care Med — New Haven

District of Columbia

  • George Washington University Medical Faculty Associates — Washington D.C.

Trial Details

FieldValue
Enrollment Target 5,614 participants
Start Date 2008-07
Est. Completion 2013-03
Phase Phase 3

Sponsor

Bristol-Myers Squibb

504 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00643201

The ClinicalTrials.gov registry entry for NCT00643201 describes a study currently listed as completed. It is categorized as Phase 3, 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 5,614 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 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 Venous Thrombosis appearing as the primary indexed condition, and to 5 interventions — of which Enoxaparin 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: NCT00643201 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Alabama. 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 NCT00643201 about?

NCT00643201 is a clinical study titled "Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism". The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

What is the current status of trial NCT00643201?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,614 participants. The study started on 2008-07. Estimated completion is 2013-03.

What conditions does trial NCT00643201 study?

This clinical trial studies the following conditions: Venous Thrombosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00643201?

The interventions under investigation include: Enoxaparin (DRUG), warfarin (DRUG), Placebo for apixaban (DRUG), Placebo for enoxaparin (DRUG), Placebo for warfarin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00643201?

This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00643201 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. 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