search
Back to results

Mixed Antagonist of Serotonin for Claudication Optimal Therapy (MASCOT)

Primary Purpose

Intermittent Claudication

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SL650472, Clopidogrel
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
March 7, 2006
Last Updated
December 18, 2008
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT00300339
Brief Title
Mixed Antagonist of Serotonin for Claudication Optimal Therapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
599 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SL650472, Clopidogrel
Primary Outcome Measure Information:
Title
Primary: percent change in initial claudication distance (ICD) measured at the 24-week test, compared with that at baseline
Secondary Outcome Measure Information:
Title
Success, defined as an improvement of > 50% in ICD at the 24-week test compared with that at baseline
Title
Percent change in absolute claudication distance (ACD) at the 24-week test, compared with that at baseline,
Title
Functional status / quality of life (QoL) using WIQ and MOS SF-36 questionnaires,
Title
Hemodynamic measurement post treadmill test (ABI/TB).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Diegem
Country
Belgium
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Praha
Country
Czech Republic
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Mexico
Country
Mexico
Facility Name
Sanofi-Aventis Administrative Office
City
Moscow
Country
Russian Federation
Facility Name
Sanofi-Aventis Administrative Office
City
Bromma
Country
Sweden
Facility Name
Sanofi-Aventis Administrative Office
City
Kiev
Country
Ukraine

12. IPD Sharing Statement

Links:
URL
http://www.sanofi-aventis.com
Description
Related Info

Learn more about this trial

Mixed Antagonist of Serotonin for Claudication Optimal Therapy

We'll reach out to this number within 24 hrs