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Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions (TAMARIS)

This study is currently recruiting participants.
Study NCT00566657.   Last updated on November 14, 2008.   Information provided by Sanofi-Aventis

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Descriptive Information Fields
Brief Title  Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions
Official Title  A Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Efficacy and Safety of XRP0038/NV1FGF on Amputation or Any Death in Critical Limb Ischemia Patients With Skin Lesions
Brief Summary

The primary objective of the study is to demonstrate the superiority of XRP0038/NV1FGF over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions.

The secondary objectives of the study are to evaluate:

  • The efficacy of XRP0038/NV1FGF versus XRP0038/NV1FGF placebo for delaying the time to death.
  • The safety of XRP0038/NV1FGF in the study population
Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Time to major amputation of the treated leg or death from any cause, whichever comes first [ Time Frame: over 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Adverse events and laboratory parameters [ Time Frame: study period ] [ Designated as safety issue: Yes ]
Condition  Peripheral Vascular Diseases
Intervention  Drug: XRP0038/NV1FGF
Drug: placebo
MEDLINE PMIDs
Links Related Info This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  490
Start Date  November 2007
Completion Date July 2010
Eligibility Criteria 

Inclusion Criteria:

  • Having peripheral artery disease at the stage of Critical Limb Ischemia (CLI) with skin lesions (either ulcer(s) or gangrene)
  • With objective evidence of CLI such as ankle systolic pressure less than 70 mmHg and/or toe systolic pressure less than 50 mmHg or TcPO2 less than 30 mm Hg
  • Unsuitable for standard revascularization of his/her peripheral arterial disease
  • Having a negative screening for cancer

Exclusion Criteria:

  • Previous major amputation on the leg to be treated or planned major amputation within the first month following randomization
  • Known Buerger's disease
  • Successful lower extremity revascularization procedure within 3 months prior randomization
  • Uncontrolled blood pressure defined as SBP≥ 180 mmHg or DBP ≥110 mmHg despite adequate antihypertensive treatment
  • Acute cardiovascular events within 3 months prior to randomization
  • Active proliferative retinopathy and severe macular oedema
  • Previous or current history of malignant disease within the past 5 years
  • Previous treatment with systemic angiogenic factors or with stem cells therapy
  • Pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender Both
Ages 50 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Public Registry ICD         GV-Contact-us@sanofi-aventis.com    
Location Countries  United States,   Argentina,   Australia,   Austria,   Belarus,   Belgium,   Brazil,   Canada,   Chile,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Italy,   Japan,   Mexico,   Poland,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   Ukraine,   United Kingdom
Administrative Information Fields
NCT ID  NCT00566657
Organization ID EFC6145
Secondary IDs †† EudraCT 2006-006277-24
Study Sponsor  Sanofi-Aventis
Collaborators ††
Investigators 
Study Director:     ICD CSD     Sanofi-Aventis    
Information Provided By Sanofi-Aventis
Verification Date November 2008
First Received Date  November 30, 2007
Last Updated Date November 14, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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