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RESTEN-MP

A Phase 1b Study Evaluating RESTEN-MP in Subjects With Focal de Novo Stenosis

Ensayo de Sarepta Therapeutics, Inc. en Coronary Artery Disease · Coronary Stent Restenosis (del registro, en inglés).

Más ensayos de: Enfermedad coronaria.

Fase

Fase 1

Estado

Interrumpido

Participantes

40

previstos

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, simple ciego. Comenzó en ago 2003.

Qué mide

Safety of a single IV slow-push injection of RESTEN-MP administered at the time of Taxus Express™ placement and over a six month surveillance period. (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe process of re-narrowing of a coronary artery following a revascularization procedure such as angioplasty, begins at the time of the procedure. Restenosis has long been considered a major problem for effective long-term interventional success. This often results in repeated procedures to deal with recurrent stenosis (or restenosis) of the original targeted vessel. There is a substantial body of literature suggesting that local MYC protein production in the injured coronary artery is a major stimulus and potential cause of restenosis that appears after stent placement. This study is based upon the hypothesis that stopping MYC protein production in the vessel has will help reduce restenosis (vessel re-narrowing). AVI BioPharma Inc., has utilized its proprietary antisense chemistry to design a drug that interferes with MYC production. This study will evaluate the safety, pharmacokinetics and potential effectiveness of a single intravenous slow-push dose of RESTEN-MP at the time of stent placement to reduce in-stent restenosis following balloon angioplasty and stent placement. The post-dose follow-up period is up to six-months.

Más ensayos de SRPT

Todos los de SRPT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00244647), actualizada en abr 2008.