Mixed Antagonist of Serotonin for Claudication Optimal Therapy

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00300339

Acronym

MASCOT

Enrollment

599

Registered

2006-03-08

Start date

2006-02-28

Completion date

2007-12-31

Last updated

2008-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Claudication

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

Interventions

DRUGSL650472, Clopidogrel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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).	—

Countries

Belgium, Canada, Czechia, Germany, Mexico, Russia, Sweden, Ukraine, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026