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See Detailed Description
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Active Comparator |
| |
| A | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalteparin (Fragmin) | Drug | Dalteparin 5000 IU once daily subcutaneously for 6-14 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Thromboembolic Events | Confirmed thromboembolic events = 'present' if any following events are present/abnormal, otherwise = 'absent': Deep vein thrombosis measured by Color Doppler ultrasonography lower limbs; pulmonary embolism by chest xray, ventilation-perfusion scan, computed tomography pulmonary angiography; Sudden Death within 24 hours of venous thromboembolism symptoms. | Day 21 |
| Composite of Objectively Verified Thromboembolic Events | Subjects with objectively verified thromboembolic events: symptomatic proximal and distal deep vein thrombosis [DVT], asymptomatic proximal DVT, fatal or symptomatic non-fatal pulmonary embolism [PE] or sudden death within 24 hours of onset of venous thromboembolism (VTE) symptoms. Occurrence of any ='Present', otherwise = 'Absent'. | Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| All Cause Mortality | Subjects with death from any cause: end of study. | Day 14, Day 21 (End of Study) |
| Stroke - Ischemic or Hemorrhagic | Subjects with stroke (either ischemic or hemorrhagic) based on results of CT (computed tomographic) pulmonary angiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Hyderabad | Andhra Pradesh | 500 068 | India | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dalteparin | 5000 IU (International Units) dalteparin in 0.2 mL (milliliters) subcutaneously once a day (Arm A) |
| FG001 | Unfractionated Heparin | 5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Unfractionated heparin |
| Drug |
Unfractionated heparin 5000 IU thrice daily subcutaneously for 6-14 days. |
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| Day 21 |
| Bleeding - Major or Minor | Subjects with bleeding. Bleeding classified as major if it is: intraocular, spinal/epidural, intracranial or retroperitoneal; or if hemoglobin decreased by ≥ 2 g/dl(grams/deciliter); or if transfusion of ≥ 2 Units of blood or if significant medical or surgical intervention was required; or if it results in death. All other bleeding is classified as minor. | Day 21 |
| Allergic Reactions (Drug-related) | Subjects with drug-related allergic reactions | Day 21 |
| Thrombocytopenia | Subjects with thrombocytopenia (low platelets). | Day 21 |
| Ahmedabad |
| Gujarat |
| 380 054 |
| India |
| Pfizer Investigational Site | Thrissur | Kerala | 680 005 | India |
| Pfizer Investigational Site | Indore | Madhya Pradesh | 452001 | India |
| Pfizer Investigational Site | Chennai | Tamil Nadu | 600 006 | India |
| Pfizer Investigational Site | Kolkata | West Bengal | 700 029 | India |
| Pfizer Investigational Site | Kolkata | West Bengal | 700 054 | India |
| Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dalteparin | 5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A) |
| BG001 | Unfractionated Heparin | 5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Confirmed Thromboembolic Events | Confirmed thromboembolic events = 'present' if any following events are present/abnormal, otherwise = 'absent': Deep vein thrombosis measured by Color Doppler ultrasonography lower limbs; pulmonary embolism by chest xray, ventilation-perfusion scan, computed tomography pulmonary angiography; Sudden Death within 24 hours of venous thromboembolism symptoms. | Intent to treat (ITT) set: all subjects who were randomized, received at least 1 dose of study drug and had undergone at least 1 test of primary efficacy assessment. | Posted | Number | participants | Day 21 |
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| Secondary | All Cause Mortality | Subjects with death from any cause: end of study. | Intent to treat (ITT) | Posted | Number | participants | Day 14, Day 21 (End of Study) |
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| Secondary | Stroke - Ischemic or Hemorrhagic | Subjects with stroke (either ischemic or hemorrhagic) based on results of CT (computed tomographic) pulmonary angiography | Intent to treat (ITT) | Posted | Number | participants | Day 21 |
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| Secondary | Bleeding - Major or Minor | Subjects with bleeding. Bleeding classified as major if it is: intraocular, spinal/epidural, intracranial or retroperitoneal; or if hemoglobin decreased by ≥ 2 g/dl(grams/deciliter); or if transfusion of ≥ 2 Units of blood or if significant medical or surgical intervention was required; or if it results in death. All other bleeding is classified as minor. | Intent to treat (ITT) | Posted | Number | participants | Day 21 |
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| Secondary | Allergic Reactions (Drug-related) | Subjects with drug-related allergic reactions | Intent to treat (ITT) | Posted | Number | participants | Day 21 |
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| Primary | Composite of Objectively Verified Thromboembolic Events | Subjects with objectively verified thromboembolic events: symptomatic proximal and distal deep vein thrombosis [DVT], asymptomatic proximal DVT, fatal or symptomatic non-fatal pulmonary embolism [PE] or sudden death within 24 hours of onset of venous thromboembolism (VTE) symptoms. Occurrence of any ='Present', otherwise = 'Absent'. | Intent to treat (ITT) | Posted | Number | participants | Day 21 |
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| Secondary | Thrombocytopenia | Subjects with thrombocytopenia (low platelets). | Intent to Treat (ITT) | Posted | Number | participants | Day 21 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dalteparin | 5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A) | 2 | 7 | ||||
| EG001 | Unfractionated Heparin | 5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days. | 4 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v12.0 | Systematic Assessment |
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| Chest pain | General disorders | Systematic Assessment |
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| Injection site rash | General disorders | Systematic Assessment |
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| Lobar pneumonia | Infections and infestations | Systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hysterosalpingo-oophorectomy | Surgical and medical procedures | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v12.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA v10.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Blood pressure increased | Investigations | Systematic Assessment |
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| Haemoglobin decreased | Investigations | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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Study terminated prematurely due to delay in overall study start-up and inability to meet predefined protocol recruitment milestones; sample size too small to permit meaningful statistical analyses. No statistical analyses for all but 2 endpoints.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D007239 | Infections |
| D015212 | Inflammatory Bowel Diseases |
| D006333 | Heart Failure |
| D012585 | Sciatica |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D006331 | Heart Diseases |
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017985 | Dalteparin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Male |
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