Clinical trial NCT00300339: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intermittent Claudication
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-03-08
Enrollment: 599
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Primary: percent change in initial claudication distance (ICD) measured at the 24-week test, compared with that at baseline
Secondary outcomes:
measure: Success, defined as an improvement of > 50% in ICD at the 24-week test compared with that at baseline
measure: Percent change in absolute claudication distance (ACD) at the 24-week test, compared with that at baseline,
measure: Functional status / quality of life (QoL) using WIQ and MOS SF-36 questionnaires,
measure: Hemodynamic measurement post treadmill test (ABI/TB).
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Diegem
country: Belgium
facility: Sanofi-Aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
city: Praha
country: Czech Republic
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Mexico
country: Mexico
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-Aventis Administrative Office
city: Kiev
country: Ukraine
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: