Mixed Antagonist of Serotonin for Claudication Optimal Therapy

Official Title: “Double-Blind, Double-Dummy, Randomized, Parallel Group Trial of SL650472 (Three Dose Regimens Versus Placebo and Cilostazol), for 24-Week Improvement of Walking Distance in Patients With Stage II Peripheral Arterial Disease Who Benefit From Optimal Prevention Strategy Including Clopidogrel”

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

Intervention(s) in this Clinical Trial

• Drug: SL650472, Clopidogrel

Primary Measures

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

Secondary Measures

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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

ICD CSD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00300339

Study ID Number: ACT4791

ClinicalTrials.gov Identifier: NCT00300339

Health Authority: United States: Food and Drug Administration