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RESTEN-MP

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

RESTEN-MP · 1 trial · 2 indications

Phase 2 1
NCT00248066Safety and Efficacy of RESTEN-MP When Used in Conjunction With a Bare Metal Stent in Coronary ArteriesCoronary Artery Disease
COMPLETED50 Analytics
PHASE2COMPLETED
Safety and Efficacy of RESTEN-MP When Used in Conjunction With a Bare Metal Stent in Coronary Arteries
Coronary Artery DiseaseUnlock trial analytics

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 to 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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Frequently asked questions about RESTEN-MP

What is RESTEN-MP used for?

RESTEN-MP is an investigational small molecule being studied for use in coronary artery disease. It was evaluated in a Phase 2 clinical trial for use in conjunction with a bare metal stent in coronary arteries, with the aim of addressing conditions such as coronary artery disease and coronary restenosis.

Who makes RESTEN-MP?

RESTEN-MP is being developed by Sarepta Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SRPT. The company conducted a Phase 2 clinical trial of this investigational drug for coronary artery disease.

What phase is RESTEN-MP in?

RESTEN-MP is an investigational drug that has completed a Phase 2 clinical trial. It is not approved by the FDA and remains in clinical development. The completed trial was an uncontrolled study that enrolled 50 participants in Germany.

What clinical trials is RESTEN-MP in?

RESTEN-MP has been studied in one completed Phase 2 clinical trial, identified as NCT00248066. The trial, titled 'Safety and Efficacy of RESTEN-MP When Used in Conjunction With a Bare Metal Stent in Coronary Arteries,' enrolled 50 participants with coronary artery disease and coronary restenosis in Germany.

Is RESTEN-MP FDA approved?

RESTEN-MP is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial for coronary artery disease. The trial was not randomized, double-blind, or controlled, and it remains in clinical development.