Mixed Antagonist of Serotonin for Claudication Optimal Therapy

Intermittent Claudication Clinical Trial

— MASCOT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00300339
• Other study ID #: ACT4791
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2006
• Last updated: December 18, 2008
• Start date: February 2006
• Est. completion date: December 2007

Study information

• Verified date: December 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 599
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease

Intervention

Drug:
• SL650472, Clopidogrel

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis Administrative Office	Diegem
Canada	Sanofi-Aventis Administrative Office	Laval
Czech Republic	Sanofi-Aventis Administrative Office	Praha
Germany	Sanofi-Aventis Administrative Office	Berlin
Mexico	Sanofi-Aventis Administrative Office	Mexico
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Sweden	Sanofi-Aventis Administrative Office	Bromma
Ukraine	Sanofi-Aventis Administrative Office	Kiev
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary: percent change in initial claudication distance (ICD) measured at the 24-week test, compared with that at baseline
Secondary	Success, defined as an improvement of > 50% in ICD at the 24-week test compared with that at baseline
Secondary	Percent change in absolute claudication distance (ACD) at the 24-week test, compared with that at baseline,
Secondary	Functional status / quality of life (QoL) using WIQ and MOS SF-36 questionnaires,
Secondary	Hemodynamic measurement post treadmill test (ABI/TB).

External Links

•   Link