Clinical Study Assessing SSR126517E Injections Once-weekly in Pulmonary Embolism Therapeutic Approach (CASSIOPEA)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00345618
First received: June 27, 2006
Last updated: October 13, 2010
Last verified: October 2010
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Purpose
To determine, in patients with clots in the lungs, whether SSR126517E is as least as effective as a standard warfarin treatment to prevent recurrence of clot in legs or lungs, and to assess its safety (bleedings) versus warfarin.
| Condition | Intervention | Phase |
|---|---|---|
|
Embolism Thrombosis |
Drug: SSR126517E Drug: warfarin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | An International, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Study of 3-month or 6-month Treatment With SSR126517E (3.0 mg s.c. Once-weekly) Versus Oral INR-adjusted Warfarin in the Treatment of Patients With Symptomatic Pulmonary Embolism With or Without Symptomatic Deep Venous Thrombosis |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Recurrence of fatal and non fatal venous thrombo-embolic events (deep vein thrombosis or pulmonary embolism) [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Recurrence of venous thrombo-embolic events at 6 months, bleedings [ Time Frame: over a 3- and 6-month period ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 3200 |
| Study Start Date: | June 2006 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: SSR126517E
subcutaneous route
|
| Active Comparator: 2 |
Drug: warfarin
oral INR-adjusted
|
Detailed Description:
Intravenous infusion of avidin (SSR29261) may be administered in case of severe bleeding, or overdose, or invasive procedure with the potential of ubncontyrolled bleeding.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis
Exclusion Criteria:
- End stage renal failure, hepatic failure, uncontrolled hypertension·
- Active bleeding or high risk for bleeding.
- Pregnancy or childbearing potential without proper contraceptive measures, threatened abortion.
- Breastfeeding.
- Known allergy to idraparinux or SSR126517E, avidin or egg proteins; hypersensitivity to warfarin, enoxaparin, heparin or pork product.
- Indication of prolonged anticoagulation for other reason than PE.
- Life expectancy < 6 months.
- Any other contraindication listed in the labelling of warfarin or enoxaparin not listed above
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345618
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Hide Study LocationsLocations
| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Argentina | |
| Sanofi-Aventis Administrative Office | |
| Buenos Aires, Argentina | |
| Australia, New South Wales | |
| sanofi-aventis Australia & New Zealand administrative office | |
| Macquarie Park, New South Wales, Australia | |
| Austria | |
| Sanofi-Aventis Administrative Office | |
| Wien, Austria | |
| Belarus | |
| Sanofi-Aventis Administrative Office | |
| Minsk, Belarus | |
| Belgium | |
| Sanofi-Aventis Administrative Office | |
| Diegem, Belgium | |
| Brazil | |
| Sanofi-Aventis Administrative Office | |
| Sao Paulo, Brazil | |
| Bulgaria | |
| Sanofi-Aventis Administrative Office | |
| Sofia, Bulgaria | |
| Canada | |
| Sanofi-Aventis Administrative Office | |
| Laval, Canada | |
| Chile | |
| Sanofi-Aventis Administrative Office | |
| Santiago, Chile | |
| China | |
| Sanofi-Aventis Administrative Office | |
| Shangai, China | |
| Colombia | |
| Sanofi-Aventis Administrative Office | |
| Santafe de Bogota, Colombia | |
| Croatia | |
| Sanofi-Aventis Administrative Office | |
| Zagreb, Croatia | |
| Czech Republic | |
| Sanofi-Aventis Administrative Office | |
| Praha, Czech Republic | |
| Denmark | |
| Sanofi-Aventis Administrative Office | |
| Horsholm, Denmark | |
| Egypt | |
| Sanofi-Aventis Administrative Office | |
| Cairo, Egypt | |
| Estonia | |
| Sanofi-Aventis Administrative Office | |
| Tallinn, Estonia | |
| France | |
| Sanofi-Aventis Administrative Office | |
| Paris, France | |
| Greece | |
| Sanofi-Aventis Administrative Office | |
| Athens, Greece | |
| India | |
| Sanofi-Aventis Administrative Office | |
| Mumbai, India | |
| Israel | |
| Sanofi-Aventis Administrative Office | |
| Natanya, Israel | |
| Italy | |
| Sanofi-Aventis Administrative Office | |
| Milano, Italy | |
| Mexico | |
| Sanofi-Aventis Administrative Office | |
| Mexico, Mexico | |
| Netherlands | |
| Sanofi-Aventis Administrative Office | |
| Gouda, Netherlands | |
| Norway | |
| Sanofi-Aventis Administrative Office | |
| Lysaker, Norway | |
| Peru | |
| Sanofi-Aventis Administrative Office | |
| Lima, Peru | |
| Philippines | |
| Sanofi-Aventis Administrative Office | |
| Makati City, Philippines | |
| Poland | |
| Sanofi-Aventis Administrative Office | |
| Warszawa, Poland | |
| Portugal | |
| Sanofi-Aventis Administrative Office | |
| Porto Salvo, Portugal | |
| Puerto Rico | |
| Sanofi-Aventis Administraive Office | |
| Puerto Rico, Puerto Rico | |
| Russian Federation | |
| Sanofi-Aventis Admnistrative Office | |
| Moscow, Russian Federation | |
| Slovakia | |
| Sanofi-Aventis Administrative Office | |
| Brastislava, Slovakia | |
| South Africa | |
| Sanofi-Aventis Administrative Office | |
| Midrand, South Africa | |
| Spain | |
| Sanofi-Aventis Administrative Office | |
| Barcelona, Spain | |
| Sweden | |
| Sanofi-Aventis Administrative Office | |
| Bromma, Sweden | |
| Turkey | |
| Sanofi-Aventis Administrative Office | |
| Istanbul, Turkey | |
| Ukraine | |
| Sanofi-Aventis Administrative Office | |
| Kiev, Ukraine | |
| United Kingdom | |
| Sanofi-Aventis Administrative Office | |
| Guildford Surrey, United Kingdom | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | ICD CSD | Sanofi |
More Information
No publications provided by Sanofi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ICD, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00345618 History of Changes |
| Other Study ID Numbers: | EFC6034, EudraCT:2006-001786-42 |
| Study First Received: | June 27, 2006 |
| Last Updated: | October 13, 2010 |
| Health Authority: | United States: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Ethics Commission |
Keywords provided by Sanofi:
|
Deep venous thrombosis pulmonary embolism anticoagulant drugs |
Additional relevant MeSH terms:
|
Embolism Pulmonary Embolism Thrombosis Venous Thrombosis Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Lung Diseases Respiratory Tract Diseases Thromboembolism Anticoagulants Warfarin Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013