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Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)

Primary Purpose

Venous Thrombosis, Deep Vein Thrombosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Xarelto (Rivaroxaban, BAY59-7939)
Xarelto (Rivaroxaban, BAY59-7939)
Xarelto (Rivaroxaban, BAY59-7939)
Xarelto (Rivaroxaban, BAY59-7939)
Enoxaparin/Vitamin K-Antagonist
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thrombosis focused on measuring Embolism and Thrombosis, Pulmonary embolism, Embolism, Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients with acute symptomatic proximal deep vein thrombosis

Exclusion Criteria:

  • Contraindication to comparator drugs
  • Symptomatic Pulmonary embolism
  • Conditions with increased bleeding risk
  • Unstable patients with reduced life expectancy
  • Severe renal impairment
  • Impaired liver function
  • Strong CYP 3A4 inhibitors
  • Platelet aggregation inhibitors (exception: ASA up to 500mg) therapy with anticoagulants or fibrinolytics
  • NSAIDs with half-life > 17 hours

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Description

Outcomes

Primary Outcome Measures

Response to treatment as determined by a Complete Compression Ultra sound (CCUS)

Secondary Outcome Measures

Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan
Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS)
Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT)
Composite endpoint of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) (nonfatal DVT and/or nonfatal PE) and deaths during the 3 months treatment period
Incidence of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) within 30 days after stop of treatment with study drug

Full Information

First Posted
February 6, 2009
Last Updated
September 6, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00839163
Brief Title
Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)
Official Title
ODIXa-DVTA Prospective, Randomized, Multinational, Multicenter, Partially Blinded, Parallel-group, Open-label Active Comparator Controlled Phase II Dose Finding and Proof of Principle Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug enoxaparin and a licensed oral vitamin K-antagonist and to find the optimal dose of BAY59-7939 for the anticipated phase III trials and for the future clinical use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis, Deep Vein Thrombosis
Keywords
Embolism and Thrombosis, Pulmonary embolism, Embolism, Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
613 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Arm Title
Arm 4
Arm Type
Experimental
Arm Title
Arm 5
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Xarelto (Rivaroxaban, BAY59-7939)
Intervention Description
10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Intervention Type
Drug
Intervention Name(s)
Xarelto (Rivaroxaban, BAY59-7939)
Intervention Description
20 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Intervention Type
Drug
Intervention Name(s)
Xarelto (Rivaroxaban, BAY59-7939)
Intervention Description
30 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Intervention Type
Drug
Intervention Name(s)
Xarelto (Rivaroxaban, BAY59-7939)
Intervention Description
40 mg od main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Intervention Type
Drug
Intervention Name(s)
Enoxaparin/Vitamin K-Antagonist
Intervention Description
Enoxaparin/Vitamin K-Antagonist main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84). Enoxaparin was to be administered 1mg/kg bid sc for about 5-7 days. It was to be discontinued when INR was within the therapeutic range 2-3 for 2 consecutive days
Primary Outcome Measure Information:
Title
Response to treatment as determined by a Complete Compression Ultra sound (CCUS)
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan
Time Frame
Day 21
Title
Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS)
Time Frame
Day 84
Title
Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT)
Time Frame
Day 1-84
Title
Composite endpoint of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) (nonfatal DVT and/or nonfatal PE) and deaths during the 3 months treatment period
Time Frame
Day 1-84
Title
Incidence of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) within 30 days after stop of treatment with study drug
Time Frame
Day 1-114

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patients with acute symptomatic proximal deep vein thrombosis Exclusion Criteria: Contraindication to comparator drugs Symptomatic Pulmonary embolism Conditions with increased bleeding risk Unstable patients with reduced life expectancy Severe renal impairment Impaired liver function Strong CYP 3A4 inhibitors Platelet aggregation inhibitors (exception: ASA up to 500mg) therapy with anticoagulants or fibrinolytics NSAIDs with half-life > 17 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Wien
ZIP/Postal Code
1171
Country
Austria
City
Duffel
ZIP/Postal Code
2570
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04544 000
Country
Brazil
City
São Paulo
State/Province
SP
ZIP/Postal Code
01323-001
Country
Brazil
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 5A4
Country
Canada
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 3B5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3N 1N1
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 3V6
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada
City
Barranquilla
Country
Colombia
City
Bogotá
Country
Colombia
City
Medellín
Country
Colombia
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
City
Kladno
ZIP/Postal Code
27259
Country
Czechia
City
Ostrava
ZIP/Postal Code
728 80
Country
Czechia
City
Plzen
ZIP/Postal Code
30599
Country
Czechia
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
City
Praha 6
ZIP/Postal Code
169 02
Country
Czechia
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69115
Country
Germany
City
Karlsbad
State/Province
Baden-Württemberg
ZIP/Postal Code
76307
Country
Germany
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68167
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64276
Country
Germany
City
Bergisch Gladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51429
Country
Germany
City
Paderborn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33098
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
City
Berlin
ZIP/Postal Code
10365
Country
Germany
City
Berlin
ZIP/Postal Code
10787
Country
Germany
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
City
Afula
ZIP/Postal Code
18101
Country
Israel
City
Ashkelon
ZIP/Postal Code
78306
Country
Israel
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Holon
ZIP/Postal Code
58100
Country
Israel
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Milano
ZIP/Postal Code
20142
Country
Italy
City
Milano
ZIP/Postal Code
20162
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Palermo
ZIP/Postal Code
90129
Country
Italy
City
Perugia
ZIP/Postal Code
06122
Country
Italy
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
City
Varese
ZIP/Postal Code
21100
Country
Italy
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
City
Den Bosch
ZIP/Postal Code
5211 RB
Country
Netherlands
City
Den Haag
ZIP/Postal Code
2512 VA
Country
Netherlands
City
Dirksland
ZIP/Postal Code
3247 BW
Country
Netherlands
City
Enschede
ZIP/Postal Code
7511 JX
Country
Netherlands
City
Leidschendam
ZIP/Postal Code
2262 BA
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3083 AN
Country
Netherlands
City
Auckland
ZIP/Postal Code
0622
Country
New Zealand
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
City
Lima Cercado
ZIP/Postal Code
LIMA 1
Country
Peru
City
Lima
ZIP/Postal Code
01
Country
Peru
City
Lima
ZIP/Postal Code
31
Country
Peru
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
City
Olsztyn
ZIP/Postal Code
10-560
Country
Poland
City
Poznan
ZIP/Postal Code
61-833
Country
Poland
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
City
Bloemfontein
State/Province
Freestate
ZIP/Postal Code
9300
Country
South Africa
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0084
Country
South Africa
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0157
Country
South Africa
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
PRETORIA
Country
South Africa
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7531
Country
South Africa
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
City
Olot
State/Province
Girona
ZIP/Postal Code
17800
Country
Spain
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Girona
ZIP/Postal Code
17007
Country
Spain
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
City
Halmstad
ZIP/Postal Code
301 85
Country
Sweden
City
Jönköping
ZIP/Postal Code
551 85
Country
Sweden
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrialsregister.eu
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)

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