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Mixed Antagonist of Serotonin for Claudication Optimal Therapy (MASCOT)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00300339
First received: March 7, 2006
Last updated: December 18, 2008
Last verified: December 2008
  Purpose

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


Condition Intervention Phase
Intermittent Claudication
Drug: SL650472, Clopidogrel
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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).

Enrollment: 599
Study Start Date: February 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300339

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Ukraine
Sanofi-Aventis Administrative Office
Kiev, Ukraine
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00300339     History of Changes
Other Study ID Numbers: ACT4791
Study First Received: March 7, 2006
Last Updated: December 18, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Intermittent Claudication
Peripheral Arterial Disease
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Peripheral Vascular Diseases
Signs and Symptoms
Vascular Diseases
Clopidogrel
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014