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NCT00132912

Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)

Completed Phase 2 Last updated 25 May 2017
What this trial tests

Phase 2 trial testing SCH 530348 in Arterial Obstructive Diseases in 1,030 participants. Completed in 28 January 2007.

Timeline
30 August 2005
Primary endpoint
28 January 2007
28 January 2007

Quick facts

Lead sponsorMerck Sharp & Dohme LLC
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment1,030
Start date30 August 2005
Primary completion28 January 2007
Estimated completion28 January 2007

Drugs / interventions tested

Conditions studied

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

45 and older, any sex, with Arterial Obstructive Diseases or Coronary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The object of the study is to determine whether different doses of SCH 530348, when added to standard medical care in persons undergoing percutaneous coronary intervention, will increase the risk of bleeding. A secondary objective is to determine whether patients treated with SCH 530348 have fewer cardiac events such as heart attack, bypass surgery, or death compared with those persons treated with the standard of care.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebo-controlled phase II study.
    Becker RC, Moliterno DJ, Jennings LK, Pieper KS, et al · · 2009 · cited 212× · PMID 19286091 · DOI 10.1016/s0140-6736(09)60230-0
  2. Procoagulant signalling mechanisms in lung inflammation and fibrosis: novel opportunities for pharmacological intervention?
    Chambers RC. · · 2008 · cited 123× · PMID 18223674 · DOI 10.1038/sj.bjp.0707603
  3. Targeting PAR1: Now What?
    Flaumenhaft R, De Ceunynck K. · · 2017 · cited 73× · PMID 28558960 · DOI 10.1016/j.tips.2017.05.001

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