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OpenTrials
Completed

NCT Number: NCT00300339

Mixed Antagonist of Serotonin for Claudication Optimal Therapy

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

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Key information

Conditions

Intermittent Claudication Cardiovascular Diseases Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office, Diegem, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SL650472, Clopidogrel

Drug

Primary outcomes

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

Secondary outcomes

  1. Success, defined as an improvement of > 50% in ICD at the 24-week test compared with that at baseline

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

  3. Functional status / quality of life (QoL) using WIQ and MOS SF-36 questionnaires,

  4. Hemodynamic measurement post treadmill test (ABI/TB).

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: MASCOT

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 8, 2006
Registry last updated
Dec 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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