drugset / Trial / NCT03236311

A Dose Titration Study to Assess the Effects of SAR407899 in Patients With MVA and/or Persistent Stable Angina Despite Angiographically Successful PCI

NCT03236311

Phase 2 Terminated 10 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Primary Objective: To assess the effects of SAR407899 on coronary vasomotor function using the coronary flow reserve (CFR) in participants with microvascular angina (MVA) and/or persistent stable angina despite angiographically successful percutaneous coronary intervention (PCI). Secondary Objectives: * To assess the effects of SAR407899 on quality of life using Seattle Angina Questionnaire physical limitation scale (SAQ-PL) in participants with MVA and/or persistent stable angina despite angiographically successful PCI. * To assess the safety of SAR407899 in participants with MVA and/or persistent stable angina despite angiographically successful PCI with a focus on identified risks such as hypotension and orthostatic hypotension. * To assess SAR407899 plasma concentrations in MVA participants and/or persistent stable angina despite angiographically successful PCI.

Timeline

Start
2017-10-12
Primary completion
2018-07-23
Completion
2018-07-23

Drugs

EvaluationDrugModalityDoseRoute
Subject SAR-407899 FREE BASE Small molecule Oral