- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00300339
Mixed Antagonist of Serotonin for Claudication Optimal Therapy (MASCOT)
December 18, 2008 updated by: Sanofi
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
599
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Diegem, Belgium
- Sanofi-Aventis Administrative Office
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Laval, Canada
- Sanofi-Aventis Administrative Office
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Praha, Czech Republic
- Sanofi-Aventis Administrative Office
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Berlin, Germany
- Sanofi-Aventis Administrative Office
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Mexico, Mexico
- Sanofi-Aventis Administrative Office
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Moscow, Russian Federation
- Sanofi-Aventis Administrative Office
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Bromma, Sweden
- Sanofi-Aventis Administrative Office
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Kiev, Ukraine
- Sanofi-Aventis Administrative Office
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis Administrative Office
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Primary: percent change in initial claudication distance (ICD) measured at the 24-week test, compared with that at baseline
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Secondary Outcome Measures
Outcome Measure |
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Success, defined as an improvement of > 50% in ICD at the 24-week test compared with that at baseline
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Percent change in absolute claudication distance (ACD) at the 24-week test, compared with that at baseline,
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Functional status / quality of life (QoL) using WIQ and MOS SF-36 questionnaires,
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Hemodynamic measurement post treadmill test (ABI/TB).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
March 7, 2006
First Submitted That Met QC Criteria
March 7, 2006
First Posted (Estimate)
March 8, 2006
Study Record Updates
Last Update Posted (Estimate)
December 19, 2008
Last Update Submitted That Met QC Criteria
December 18, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Intermittent Claudication
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Clopidogrel
Other Study ID Numbers
- ACT4791
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intermittent Claudication
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Mid and South Essex NHS Foundation TrustRecruitingPeripheral Arterial Disease | Claudication, IntermittentUnited Kingdom
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Louis MessinaBioMarin PharmaceuticalRecruitingPeripheral Vascular Diseases | Peripheral Artery Disease | Claudication, IntermittentUnited States
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University Hospital, AngersCompletedPeripheral Artery Disease | Claudication, IntermittentFrance
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Palo Alto Veterans Institute for ResearchSociety for Vascular SurgeryWithdrawnPeripheral Artery Disease | Claudication, Intermittent
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Biotronik AGCompletedSevere Intermittent Claudication | Patients With Symptomatic Critical Limb IschemiaGermany
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University Hospital, EssenStraub Medical AGUnknownPeripheral Arterial Disease | Claudication, IntermittentGermany
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University Hospital, EssenUnknownPeripheral Arterial Disease | Claudication, IntermittentGermany
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Sheffield Teaching Hospitals NHS Foundation TrustUniversity Hospital, Angers; Imperial College London; Sheffield Hallam UniversityCompletedIntermittent ClaudicationUnited Kingdom
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Paradigm SpineCompletedIntermittent Neurogenic Claudication (INC) as a Result of Spinal StenosisNetherlands
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Imperial College LondonTerminatedStandardised Claudication Treadmill TestUnited Kingdom
Clinical Trials on SL650472, Clopidogrel
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Korea University Anam HospitalCompleted
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Chinese PLA General HospitalUnknownCLOPIDOGREL, POOR METABOLISM of (Disorder)China
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Ospedale San DonatoCompletedAcute Myocardial InfarctionItaly
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University of PecsTerminatedStable Angina Pectoris | Ad Hoc Percutaneous Coronary InterventionHungary
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University of North Carolina, Chapel HillCompleted
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Hospital Central San Luis Potosi, MexicoUnknownAcute Coronary Syndrome
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Lady Reading Hospital, PakistanPakistan Chest Society, PakistanRecruitingCOPD | COPD Exacerbation AcutePakistan
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Deutsches Herzzentrum MuenchenTerminatedCoronary Artery DiseaseGermany
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Seung-Jung ParkCardioVascular Research Foundation, KoreaCompleted