Status:
COMPLETED
Mixed Antagonist of Serotonin for Claudication Optimal Therapy
Lead Sponsor:
Sanofi
Conditions:
Intermittent Claudication
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
To investigate in patients suffering from intermittent claudication due to Fontaine stage II PAD whether a 24-week treatment by SL650472 OD on top of clopidogrel may result in an improvement of walkin...
Eligibility Criteria
Inclusion
- 1\. Patient with stable symptoms of intermittent claudication of the lower extremities, secondary to chronic occlusive arterial disease from atherosclerosis origin (symptoms present for 6 months or longer and not significantly changed within the past 3 months);
- 2\. ICD of 30 to 200 m at screening constant workload treadmill test
- 3\. Doppler-measured pre-treadmill ABI of 0.90 or lower after 10 minutes of rest or, for patients with an ABI of greater than 1.3 (non-compressible arteries), a Toe-Brachial Index (TBI) of less than 0.7.
Exclusion
- 1\. Age below 40 years and/or onset of symptoms of PAD before the age of 40 years;
- 2\. Non-atherosclerotic vascular disease (e.g. Buerger's disease, popliteal entrapment syndrome);
- 3\. Limb-threatening (grades III and IV) chronic limb ischemia, manifested by ischemic rest pain, ulceration, or gangrene.
- 4\. Patients with a history of malignant or proliferate breast disease.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
599 Patients enrolled
Trial Details
Trial ID
NCT00300339
Start Date
February 1 2006
End Date
December 1 2007
Last Update
December 19 2008
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Diegem, Belgium
3
Sanofi-Aventis Administrative Office
Laval, Canada
4
Sanofi-Aventis Administrative Office
Prague, Czechia