Mixed Antagonist of Serotonin for Claudication Optimal Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00300339
• Date of registration: 07/03/2006
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Mixed Antagonist of Serotonin for Claudication Optimal Therapy MASCOT
• Scientific 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
• Date of first enrolment: February 2006
• Target sample size: 599
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00300339
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, Czech Republic, Germany, Hungary, Mexico, Russian Federation, Sweden, Ukraine, United States

Contacts

• Name: ICD CSD
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Intermittent Claudication

Intervention(s)

Drug: SL650472, Clopidogrel

Primary Outcome(s)

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

Secondary Outcome(s)

Success, defined as an improvement of > 50% in ICD 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).

Percent change in absolute claudication distance (ACD) at the 24-week test, compared with that at baseline,

Secondary ID(s)

ACT4791

Source(s) of Monetary Support

Please refer to primary and secondary sponsors