Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

March 7, 2007

Last Updated Date

October 5, 2009

Start Date ^ICMJE

June 2007

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Confirmed Thromboembolic Events [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
Composite of Objectively Verified Thromboembolic Events [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Composite of objectively confirmed thromboembolic events at day 21

Change History

Complete list of historical versions of study NCT00445328 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

All Cause Mortality [ Time Frame: Day 14, Day 21 (End of Study) ] [ Designated as safety issue: Yes ]
Stroke - Ischemic or Hemorrhagic [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
Bleeding - Major or Minor [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
Allergic Reactions (Drug-related) [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
Thrombocytopenia [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

All-cause mortality Stroke defined either as ischemic or hemorrhagic Major and minor bleeding and symptomatic DVT or asymptomatic proximal DVT at end of treatment period and on day 21

Descriptive Information

Brief Title ^ICMJE

Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients

Official Title ^ICMJE

Prospective Randomized Phase IV Open Label Comparative Study Of Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients.

Brief Summary

The purpose of this study is to compare the efficacy and safety of dalteparin vs unfractionated heparin for the prevention of VTE (Venous Thromboembolism) in hospitalized acutely ill medical patients.

Detailed Description

The study was prematurely discontinued due to delay in overall study start-up and inability to meet pre-defined protocol recruitment milestones on June 30th, 2008. There were no safety concerns regarding the study in the decision to terminate the trial.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Venous Thromboembolism

Intervention ^ICMJE

Drug: Dalteparin (Fragmin)
Drug: Unfractionated heparin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Aged greater than or equal to 18 years
Acute medical condition with a projected hospitalization of greater than or equal to 4 days and had less than or equal to 3 days of prior immobilization for more than two thirds of the day
Acute congestive heart failure Class III-IV per NHYA/ Acute respiratory failure not requiring mechanical ventilation or Both
Acute infection without septic shock/ Acute episode of inflammatory bowel disease/ Acute rheumatologic disorders/ Acute lumbar pain or sciatica or vertebral compression with at least one risk factor for VTE

Exclusion Criteria:

Contraindications to use of anticoagulants
Active bleeding or abnormal coagulation tests
Recent (less than 1 month) head injury, hemorrhagic stroke, cerebral tumor or intracranial aneurysm or ischemic stroke within the last month.
Major surgical or invasive procedure within the last month resulting in ongoing convalescence
Lumbar or spinal puncture within last 48 hours
S creatinine levels more than 2
On inotropic agents

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

India

Administrative Information

NCT ID ^ICMJE

NCT00445328

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer Inc

Study ID Numbers ^ICMJE

A6301080

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP