Mixed Antagonist of Serotonin for Claudication Optimal Therapy

Phase 2

Completed

• Conditions: Intermittent Claudication

• Registration Number: NCT00300339
• Lead Sponsor: Sanofi

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 walking capacity, by comparing three doses of SL650472 to placebo, and to calibrate such effect versus cilostazol

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-03-07
• Study First Submitted QC: 2006-03-07
• Study First Posted: 2006-03-08
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-18
• Last Update Posted: 2008-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 599

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary: percent change in initial claudication distance (ICD) measured at the 24-week test, compared with that at baseline

Secondary Outcome Measures

Name	Time	Method
Success, defined as an improvement of > 50% in ICD at the 24-week test compared with that at baseline
Hemodynamic measurement post treadmill test (ABI/TB).
Functional status / quality of life (QoL) using WIQ and MOS SF-36 questionnaires,
Percent change in absolute claudication distance (ACD) at the 24-week test, compared with that at baseline,

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇺🇦 Kiev, Ukraine