A Comparison of Certoparin and Unfractionated Heparin in... | NCT00451412

Studies
A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical Patients

NCT00451412

Sponsor

Novartis

Status

Completed

Last Update Posted

Jul 25, 2012Estimated

Enrollment

3,254Actual

Phase

Phase 3

Conditions

Thromboembolism

Interventions

Certoparin
Unfractionated Heparin

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Mar 21, 2007

First Submission Date that Met QC Criteria

Mar 22, 2007

First Posted Date

Mar 23, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2012

Last Update Posted Date

Jul 25, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3,254Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Certoparin	Experimental		Drug: Certoparin
Unfractionated Heparin	Active Comparator		Drug: Unfractionated Heparin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Certoparin	Drug	3000 U anti XA of certoparin in 0.3 ml solution, once daily	Certoparin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism)		20 days

Secondary Outcomes

Measure	Description	Time Frame
proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening,		20 days
symptomatic DVT,		20 days
symptomatic non-fatal pulmonary embolism (PE),

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospitalized medical patients 70 years of age or older
Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances)
written informed consent

Exclusion Criteria:

immobilization longer than 3 days prior to randomization
prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system
expected major surgical or invasive procedure within the next 3 weeks after randomization
LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization
immobilization due to cast or fracture
indication for anticoagulatory or thrombolytic therapy
acute symptomatic DVT / PE
known hypersensitivity to any of the study drugs or drugs with similar chemical structures
Acute or history of heparin induced thrombocytopenia type II (HIT II)

Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis	Novartis	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21791091	Derived	Haas S, Schellong SM, Tebbe U, Gerlach HE, Bauersachs R, Melzer N, Abletshauser C, Sieder C, Bramlage P, Riess H. Heparin based prophylaxis to prevent venous thromboembolic events and death in patients with cancer - a subgroup analysis of CERTIFY. BMC Cancer. 2011 Jul 26;11:316. doi: 10.1186/1471-2407-11-316.
21505722	Derived

ID	Term
D013923	Thromboembolism
D054556	Venous Thromboembolism
D020246	Venous Thrombosis
D016769	Embolism and Thrombosis

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D013927	Thrombosis

ID	Term
C403769	certoparin
C089749	Sandoparin
C031388	heparin-dihydergot
D006495	Heparin, Low-Molecular-Weight
D006493	Heparin

ID	Term
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates