Total Hip Replacement Study Of GSK576428 (Fondaparinux Sodium)

NCT00320398 | Completed Phase 3 Results

• 1 other identifier: AR3106333
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).

Conditions

Thrombosis, Venous

Keywords

Fondaparinux; Hip Replacement Arthroplasty; VTE; THR; MOSLL; pentasaccharide; Xa factor

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Venous Thromboembolism (VTE) During Efficacy Period

  The percentage of participants with VTE, who underwent elective total hip replacement surgery, detected by routine venography, during the treatment period were reported. The percentage VTE was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).

  Up to Day 17

• Percentage of Participants With Major Bleeding

  Major bleeding defined as any clinically unusual bleeding meeting 1 of following criteria; a)Fatal bleeding; b) Including retroperitoneal and intracranial bleeding, or bleeding into critical organ (eye, adrenal gland, pericardium, spine); c) Reoperation due to bleeding or hematoma at operative site; d)Bleeding leading to hemoglobin (Hb) fall \> = 2 gram per deciliter (g/dL)(1.6 millimole per litre \[mmol/L\]) within 48 hour of the bleed; e)Bleeding that required transfusion of red blood cells (RBCs) or whole blood (WB) derived from \>= 900 milliliter (mL) of WB within 48 hours of the bleed (excluding autologous transfusion except for treatment of bleeding adverse event); f) Bleeding leading to bleeding index (BI) \>=2. The percentage was calculated by the number of events divided by the number of participants evaluated multiplied by 100. This was adjudicated by the CIACE.

  Up to Day 17

Secondary Outcomes (9)

• Percentage of Participants With Minor Bleeding

  Up to Day 17

• Percentage of Participants With All Deep Vein Thrombosis (DVT)

  Up to Day 17

• Percentage of Participants With Proximal DVT

  Up to Day 17

• Percentage of Participants With Distal Only DVT

  Up to Day 17

• Percentage of Participants With Symptomatic DVT During Main Efficacy Period

  Up to Day 17

Interventions

Fondaparinux DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing either an elective primary THR (total hip replacement) surgery or a revision of a THR.

You may not qualify if:

• Active, clinically significant bleeding (excluding drainage).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2006
• First Posted: May 3, 2006
• Study Start: January 30, 2006
• Primary Completion: July 18, 2006
• Study Completion: July 18, 2006
• Last Updated: September 4, 2018
• Results First Posted: December 21, 2017

Record last verified: 2018-08