Clinical Trials Logo

Clinical Trial Summary

Primary objective is to demonstrate the superiority of riferminogene pecaplasmid 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.

Secondary objectives are to evaluate:

- The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation;

- The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death;

- The safety of riferminogene pecaplasmid in the study population.


Clinical Trial Description

The study consists in 6-week treatment then a follow-up period up to 12 months. A follow-up contact is then scheduled 6 months later.

Per protocol amendment a 18-month long-term safety survey was added. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00566657
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date November 2007
Completion date August 2012

See also
  Status Clinical Trial Phase
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Completed NCT00536796 - Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets N/A
Completed NCT00371371 - Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI) Phase 1/Phase 2
Recruiting NCT00173602 - The Burden of Peripheral Artery Occlusion Disease and Associated Factors in Peritoneal Dialysis Patients N/A
Completed NCT00228384 - GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study Phase 4
Completed NCT00163267 - Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel Phase 2/Phase 3
Completed NCT00106327 - Improving Functioning in Peripheral Arterial Disease N/A
Completed NCT00049907 - Cardiac and Renal Disease Study (CARDS) N/A
Completed NCT00000614 - Prevention of Recurrent Venous Thromboembolism (PREVENT) Phase 3
Completed NCT00005392 - Epidemiology of Venous Disease N/A
Recruiting NCT05596760 - Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers N/A
Recruiting NCT00539266 - Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia Phase 2/Phase 3
Completed NCT00541307 - GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER) N/A
Completed NCT00520312 - Magnetic Resonance Imaging to Identify Characteristics of Plaque Build-Up in People With Peripheral Arterial Disease N/A
Terminated NCT00504088 - Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia Phase 4
Completed NCT00533104 - Cell Therapy in Chronic Limb Ischemia Phase 1/Phase 2
Enrolling by invitation NCT05459818 - Individual Patient Data Analysis of Viabahn for Peripheral Arterial Disease
Completed NCT03875846 - Intraoperative Simultaneous Pressure Guided Revascularization Study
Active, not recruiting NCT05110677 - Pilot Study of Topographic Imaging of the Calf Muscle in Patients With PAD Using 3D Reconstruction of MSOT Images
Active, not recruiting NCT02856230 - An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK) Phase 2/Phase 3