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NCT00300339: 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
Phase 2 trial testing SL650472, Clopidogrel in Intermittent Claudication in 599 participants. Completed in 1 December 2007.
1 December 2007
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 599 |
| Start date | 1 February 2006 |
| Primary completion | 1 December 2007 |
| Estimated completion | 1 December 2007 |
| Sites | 9 locations across United States, Belgium, Canada, Czechia, Germany, Mexico, Russia, Sweden |
Drugs / interventions tested
- SL650472, Clopidogrel — full drug profile →
Conditions studied
- Intermittent Claudication — all drugs for Intermittent Claudication →
Sponsor
Sanofi — full company profile →
Who can join
40 and older, any sex, with Intermittent Claudication. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- Primary: percent change in initial claudication distance (ICD) measured at the 24-week test, compared with that at baseline
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Cilostazol for intermittent claudication.
Brown T, Forster RB, Cleanthis M, Mikhailidis DP, et al · · 2021 · cited 29× · PMID 34192807 · DOI 10.1002/14651858.cd003748.pub5
Verify or expand the search:
- PubMed search for NCT00300339
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Intermittent Claudication
Currently open trials in the same condition.
- NCT06686121 — Improving Mobility After Revascularization in Peripheral Artery Disease · Phase 3 · recruiting
- NCT06657976 — Response to Exercise and Nitric Oxide in PAD · Phase 2 · recruiting
- NCT05457738 — Home-based Exercice Therapy for Patients With Intermittent Claudication Using a New Smartphone Application · NA · recruiting
- NCT06114732 — Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in Intermittent Claudicat · NA · recruiting
- NCT05132439 — MetfOrmin BenefIts Lower Extremities With Intermittent Claudication · Phase 3 · recruiting
Other Sanofi trials
Trials by the same sponsor.
- NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
- NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
- NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
- NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
- NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00300339 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanofi
- Last refreshed: 18 December 2008
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00300339.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing