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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00252005




Registration number
NCT00252005
Ethics application status
Date submitted
9/11/2005
Date registered
11/11/2005
Date last updated
2/03/2010

Titles & IDs
Public title
Oral Direct Factor Xa-inhibitor Apixaban in Patients With Acute Symptomatic Deep-vein Thrombosis-The Botticelli DVT Study
Scientific title
Protocol CV185017: A Phase 2 Randomized, Parallel-Arm Study of Oral Direct Factor Xa-Inhibitor Apixaban and Low Molecular Weight Heparin or Fondaparinux With A Vitamin K Antagonist In Subjects With Acute Symptomatic Deep-Vein Thrombosis
Secondary ID [1] 0 0
CV185-017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep-Vein Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Apixaban

Treatment: Drugs: Apixaban
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The composite of symptomatic recurrent venous thromboembolism (i.e., recurrent deep-vein thrombosis or fatal or non-fatal pulmonary embolism and deterioration of the thrombotic burden as assessed by repeat bilateral
Timepoint [1] 0 0
Primary outcome [2] 0 0
compression ultrasound and perfusion lung scan.
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
1. Subjects must be willing and able to give written informed consent.

2. Confirmed acute symptomatic DVT, i.e., proximal vein or extensive calf-vein
thrombosis, involving at least the upper third part of the deep calf veins
(trifurcation area) without concomitant symptomatic PE.

3. Women and men, ages 18 (or legal age of consent) to 90. Women of childbearing
potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy
throughout the study and for up to 1 week after the study in such a manner that the
risk of pregnancy is minimized.

WOCBP include any female who has experienced menarche and who has not undergone successful
surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy)
or is not postmenopausal [defined as amenorrhea for 12 consecutive months; or women on
hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH)
level > 35mIU/mL]. Even women who are using oral, implanted or, injectable contraceptive
hormones or mechanical products such as an intrauterine device or barrier methods
(diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where
partner is sterile (e.g., vasectomy), should be considered to be of child bearing
potential. WOCBP must have negative serum or urine pregnancy test (minimum sensitivity
25IU/L or equivalent units of HCG) within 24 hours prior to the start of study medication.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are pregnant or breastfeeding.

2. Women with a positive pregnancy test on enrollment or prior to study drug
administration.

3. More than 24 hours pre-randomization treatment with therapeutic dosages of
unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or
more than a single starting dose of vitamin K antagonist (VKA) prior to randomization.

4. Uncontrolled hypertension: systolic blood pressure > 200 mm Hg or diastolic blood
pressure > 110 mm Hg.

5. Creatinine clearance < 30 mL/min

6. Impaired liver function (ALT > 3 x ULN)

7. Use of ASA > 165 mg/day

8. WOCBP who are unwilling or unable to use an acceptable method of birth control to
avoid pregnancy for the entire study period and for up to 1 week after the study.

9. Azole antifungals (e.g., ketoconazole), HIV protease inhibitors (e.g., ritonavir) and
macrolide antibiotics (e.g., erythromycin).

NOTE: topical azole antifungal agents are permitted.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Garran
Recruitment hospital [2] 0 0
Local Institution - Caringbah
Recruitment hospital [3] 0 0
Local Institution - Kogarah
Recruitment hospital [4] 0 0
Local Institution - Randwick
Recruitment hospital [5] 0 0
Local Institution - Bedford Park
Recruitment hospital [6] 0 0
Local Institution - Box Hill
Recruitment hospital [7] 0 0
Local Institution - Clayton
Recruitment hospital [8] 0 0
Local Institution - Melbourne
Recruitment hospital [9] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Caringbah
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Randwick
Recruitment postcode(s) [5] 0 0
- Bedford Park
Recruitment postcode(s) [6] 0 0
- Box Hill
Recruitment postcode(s) [7] 0 0
- Clayton
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment postcode(s) [9] 0 0
- Perth
Recruitment outside Australia
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United States of America
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New Mexico
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United States of America
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North Carolina
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Austria
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Graz
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Austria
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Wien
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Czech Republic
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Hradec Kralove
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Czech Republic
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Karlovy Vary
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Czech Republic
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Ostrava 1
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Czech Republic
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Ostrava Poruba
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Czech Republic
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Plzen
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Czech Republic
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Praha 1
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Czech Republic
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Praha 2
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Czech Republic
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Usti Nad Labem
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France
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Angers
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France
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Brest Cedex
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France
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Clermont-Ferrand Cedex 01
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France
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Creteil
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Limoges
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Montpellier
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Paris
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France
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Saint Etienne
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Israel
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Afula
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Israel
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Ashkelon
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Israel
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Haifa
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Kfar-Saba
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Israel
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Petach Tikva
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Israel
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Safed
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Israel
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Tel Aviv
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Italy
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Chieti
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Italy
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Milano
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Italy
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Padova
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Italy
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Pavia
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Italy
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Piacenza
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Italy
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Reggio Emilia
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Italy
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Treviso
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Italy
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Venezia
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Netherlands
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Amsterdam
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Netherlands
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Arnhem
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Netherlands
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Groningen
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Netherlands
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Hoofddorp
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Netherlands
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Maastricht
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Netherlands
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Zwolle
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Poland
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Bydgoszcz
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Katowice
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Lublin
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Wroclaw
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Free State
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South Africa
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Gauteng
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South Africa
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Western Cape
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Sweden
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Boras
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Goteborg
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Halmstad
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Sweden
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Jonkoping
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Stockholm
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Sweden
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Vastervik

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this clinical research study is to assess efficacy and safety of 3 doses of
apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional
treatment with low molecular weight heparin or fondaparinux and vitamin K antagonist in the
treatment of subjects with acute symptomatic deep-vein thrombosis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00252005
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00252005