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RESTEN-MP

Phase 2

Coronary Artery Disease | Small molecule | Cardiovascular |Sarepta Therapeutics, Inc.|Last Updated: Feb 8, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00248066Safety and Efficacy of RESTEN-MP When Used in Conjunction With a Bare Metal Stent in Coronary ArteriesPHASE2 COMPLETED 50 — — Sep 1, 2005 -Feb 8, 20073 Germany
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Study Endpoints
Primary Endpoints
Evaluate the potential efficacy of RESTEN-MP given intravenously upon confirmation of stent implantation and again at 24 hours post-stent implantation
The therapeutic endpoint to assess potential efficacy is the prevention of coronary late lumen loss 6 months after the stent placement procedure, based on quantitative coronary angiography (QCA).
Secondary Endpoints
Major adverse cardiac events (MACE) defined as cardiac death, MI (Q wave and non-Q wave), emergent cardiac bypass surgery, and clinically-driven target lesion revascularization (TLR) at Days 14 and 30, and Month 6, 9 and 12 post-stent placement
Target vessel failure (TVF) rate, defined as a composite of target vessel revascularization, recurrent MI (Q or Non Q-Wave), or cardiac death that could not be clearly attributed to a vessel other than the target vessel at Month 9 post-stent placement
Angiographic binary restenosis (≥ 50% diameter stenosis) at Month 6 post-stent placement
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
RESTEN-MPDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. ≥ 18 years of age. 2. An acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), coronary artery stenting, and emergent coronary artery bypass graft (CABG). 3. Clinical evidence of ischemic heart disease or a positive functional study. 4. The target le...

Countries:Germany
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Competitive Landscape -Coronary Artery Disease 99 trials
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