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Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion

This study has been completed.

Sponsors and Collaborators: Nuvelo
Health Decisions
Information provided by: Nuvelo
ClinicalTrials.gov Identifier: NCT00073554
  Purpose

This trial is for patients with acute occlusion of one of the arteries supplying blood to the leg. The trial is designed to determine the safety and activity of a novel clot dissolving (thrombolytic) drug (alfimeprase).


Condition Intervention Phase
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Thrombosis
Drug: Alfimeprase
Phase II

MedlinePlus related topics:   Peripheral Arterial Disease    Vascular Diseases   

Drug Information available for:   Alfimeprase   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Phase 2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Alfimeprase in Patients With Acute Peripheral Arterial Occlusion

Further study details as provided by Nuvelo:

Estimated Enrollment:   100
Study Start Date:   June 2003

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
  • Patients with acute peripheral arterial occlusion of the lower limb (onset of symptoms within 14 days)
  • Rutherford Class I or IIa (minimal sensory loss, no muscle weakness, audible venous flow)
  • Age 18 or above
  • Able to consent
  • Able to follow up
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073554

Locations
United States, Ohio
Cleveland Clinic Foundation    
      Cleveland, Ohio, United States

Sponsors and Collaborators
Nuvelo
Health Decisions
  More Information


Alfimeprase Information  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   HA002, NAPA-1
First Received:   November 24, 2003
Last Updated:   February 16, 2007
ClinicalTrials.gov Identifier:   NCT00073554
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Arterial Occlusive Diseases
Embolism and Thrombosis
Peripheral Vascular Diseases
Embolism
Vascular Diseases
Thrombosis

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2008




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