Mixed Antagonist of Serotonin for Claudication Optimal Therapy

Condition(s) targeted: Intermittent Claudication

Intervention: SL650472, Clopidogrel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Sanofi-Aventis

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

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

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).

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

sanofi-aventis Belgium, Diegem, Belgium

Sanofi-Aventis, Laval, Canada

Sanofi-Aventis, Praha, Czech Republic

sanofi-aventis Germany, Berlin, Germany

Sanofi-Aventis, Mexico, Mexico

sanofi-aventis Russia, Moscow, Russian Federation

Sanofi-Aventis, Bromma, Sweden

Sanofi-aventis, Kiev, Ukraine

Sanofi-Aventis, Bridgewater, New Jersey 08807, United States

Starting date: February 2006
Last updated: March 13, 2008