FindTrial
Sign In

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

MULTINATIONAL CLINICAL TRIAL, MULTICENTRIC, PHASE II PROSPECTIVE, RANDOMIZED, PARTIALLY BLIND, OF PARALLEL GROUPS, CONTROLLED WITH AN UNDASMATED ACTIVE COMPARATOR OF DOSE SEARCH AND EVALUATION OF DRUG BAY 59-7939 (DIRECT ORAL INHIBITOR OF FACTOR XA) IN THE TREATMENT OF PATIENTS WITH TRUNBOSIS VENOUS DEEP PROXIMAL ACUTE SYMPTOMATIC (STUDIO ODIXA-DVT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-056-04
Enrollment
22
Registered
2004-09-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

10 mg bid de BAY 59-7939 Type of group
10 mg bid of BAY 59-7939 will be administered for 21 days. Group name:Enoxaparin sodium Type of group
Enoxaparin sodium (injectable) / vitamin K antagonists are given as tablets for 21 days.

Sponsors

BAYER S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with acute symptomatic proximal deep vein thrombosis. Men or women over 18 years of age.

Exclusion criteria

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

Design outcomes

Secondary

MeasureTime frame
Outcome name:Response to treatment as determined by a complete compression ultrasound (CCUS) and a pulmonary perfusion scan Measure:Response to treatment as determined by a complete compression ultrasound (CCUS) and a pulmonary perfusion scan Timepoints:21 days—

Primary

MeasureTime frame
Outcome name:Response to treatment as determined by a Complete Compression Ultra sound Measure:Response to treatment as determined by a Complete Compression Ultra sound Timepoints:21 days—

Countries

Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, South Africa, Spain, Sweden, Switzerland

Outcome results

None listed

Source: REPEC (via WHO ICTRP)