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Completed Phase 3 Interventional Results available

Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty

ClinicalTrials.gov ID: NCT00657150

Public ClinicalTrials.gov record NCT00657150. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 12:57 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Orally Administered 220 mg Dabigatran Etexilate Capsules (110 mg Administered on the Day of Surgery Followed by 220 mg Once Daily) Compared to Subcutaneous 40 mg Enoxaparin Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Arthroplasty Surgery. (RE-NOVATE II)

Study identification

NCT ID
NCT00657150
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
2,055 participants

Conditions and interventions

Interventions

  • Enoxaparin Drug
  • Dabigatran etexilate Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 29, 2008
Primary completion
Aug 31, 2009
Completion
Not listed
Last update posted
Jul 1, 2014

Started 2008

United States locations

U.S. sites
10
U.S. states
8
U.S. cities
10
Facility City State ZIP Site status
1160.64.01005 Boehringer Ingelheim Investigational Site La Jolla California
1160.64.01010 Boehringer Ingelheim Investigational Site Aurora Colorado
1160.64.01009 Boehringer Ingelheim Investigational Site Englewood Colorado
1160.64.01012 Boehringer Ingelheim Investigational Site Clearwater Florida
1160.64.01006 Boehringer Ingelheim Investigational Site Lexington Kentucky
1160.64.01003 Boehringer Ingelheim Investigational Site Missoula Montana
1160.64.01007 Boehringer Ingelheim Investigational Site Charleston South Carolina
1160.64.01013 Boehringer Ingelheim Investigational Site Conway South Carolina
1160.64.01002 Boehringer Ingelheim Investigational Site Houston Texas
1160.64.01011 Boehringer Ingelheim Investigational Site Spokane Washington

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 98 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00657150, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 1, 2014 · Synced Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00657150 live on ClinicalTrials.gov.

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