NCT00300339|CompletedPhase 2

Mixed Antagonist of Serotonin for Claudication Optimal Therapy

MASCOT

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

Sanofi ClinicalTrials.gov

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1 other identifier

ACT4791

Study Type

interventional

Target

599

Locations

9 countries

Sites

Timeline

RegisteredMar 2006

StartedFeb 2006

CompletionDec 2007

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

599

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Feb 2006

Geographic Reach

9 countries

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

Study Start

First participant enrolled

February 1, 2006

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2006

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed

Last Updated

December 19, 2008

Status Verified

December 1, 2008

Enrollment Period

1.8 years

First QC Date

March 7, 2006

Last Update Submit

December 18, 2008

Conditions

Intermittent Claudication

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

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).

Interventions

SL650472, ClopidogrelDRUG

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

\. 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);
\. ICD of 30 to 200 m at screening constant workload treadmill test
\. 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.

You may not qualify if:

\. Age below 40 years and/or onset of symptoms of PAD before the age of 40 years;
\. Non-atherosclerotic vascular disease (e.g. Buerger's disease, popliteal entrapment syndrome);
\. Limb-threatening (grades III and IV) chronic limb ischemia, manifested by ischemic rest pain, ulceration, or gangrene.
\. Patients with a history of malignant or proliferate breast disease.

Contact the study team to confirm eligibility.