Efficacy of Bemiparin Versus Enoxaparin in the Treatment of DVT
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|ClinicalTrials.gov Identifier: NCT01880216|
Recruitment Status : Completed
First Posted : June 18, 2013
Last Update Posted : February 4, 2016
Deep-vein thrombosis (DVT) is a common but under-diagnosed medical condition that occurs when a thrombus forms in one of the large veins, usually in the lower limbs, leading to either partial or complete blocked circulation. The condition may progress to severe health complications, such as pulmonary embolism (PE), if not diagnosed and treated in a timely and effective manner.
The goal of the therapy for lower-extremity DVT is to prevent the extension of thrombus and pulmonary embolism in the short term and to prevent recurrent events in the long-term. Although anticoagulant therapy decreases the risk of recurrent thrombosis, the treatment also increases the risk for major hemorrhage.
This trial aims to optimize the current medical knowledge on the effectiveness and safety of two low molecular weight heparins, bemiparin and enoxaparin in the treatment of deep vein thrombosis.
|Condition or disease||Intervention/treatment||Phase|
|Deep Vein Thrombosis||Drug: Bemiparin sodium Drug: Enoxaparin sodium||Phase 3|
The aim of this study is to demonstrate the therapeutic non-inferiority of bemiparin sodium (LMWH) versus enoxaparin sodium (LMWH) during a 7±2 days treatment period and a follow up of 11 weeks observation period.
The percentage of patients with an improvement in thrombotic burden at Visit 3 (Day 83) defined as a ≥4-point reduction in thrombus score (or at least halving the thrombus score, when the total score is ≤ 6), without confirmed symptomatic extension of recurrence of DVT, confirmed symptomatic PE, or VTE-related death at Visit 3 (Day 83 / Month 3), as measured by complete compression ultrasound (cCUS) by Duplex sonography according to a standardized protocol.
The secondary efficacy endpoints are defined as the:
• Incidence of symptomatic venous thromboembolic events (VTE) at Visit 3 (Day 83:
- Recurrent DVT
- Pulmonary embolism
Patients with acute deep-vein thrombosis of the leg (DVT) with symptoms of less than 14 days, confirmed by complete compression ultrasound (cCUS) within 48 hours prior study start.
Patients who have given their signed declaration of consent and data protection declaration Males and females aged 18 years
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||312 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Multinational, Multicentre, Randomized, Open, Parallel Group Study on the Efficacy and Safety of Bemiparin Sodium (LMWH) Compared to Enoxaparin Sodium (LMWH) in the Treatment of Acute Deep Vein Thrombosis (DVT)|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||May 2015|
Active Comparator: Enoxaparin sodium
subcutaneous for 7±2 days and starting on Day 2 additionally the oral anticoagulant warfarin
Drug: Enoxaparin sodium
subcutaneous for 7±2 days
Other Name: LMWH; CAS 73334-07-3
Experimental: Bemiprin sodium
Bemiparin sodium (LMWH) s.c. for 7±2 days and starting on Day 2 additionally the oral anticoagulant warfarin
Drug: Bemiparin sodium
subcutaneous application daily for 7±2 days
Other Name: LMWH; CAS 874-98-4
- Percentage of patients with an improvement in thrombotic burden at Visit 3 [ Time Frame: 83±7 days ]
- Incidence of symptomatic venous thromboembolic events (VTE) [ Time Frame: 83±7 days ]
- Treatment emergent adverse events (TEAEs) [ Time Frame: 83±7 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880216
|Study Chair:||Maria Th Kaltwasser, Dr.||Berlin-Chemie AG|