Last updated on December 2018

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


Brief description of study

Primary Objective:

To assess the effects of SAR407899 on coronary vasomotor function using the coronary flow reserve (CFR) in patients 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 domain (SAQ-PL) in patients with MVA and/or persistent stable angina despite angiographically successful PCI.
  • To assess the safety of SAR407899 in patients 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 patients and/or persistent stable angina despite angiographically successful PCI.

Detailed Study Description

The total duration of study per subject is:

  • up to 9 weeks for patients with previous coronary artery angiography or coronary computed tomography angiography (CCTA) within 24 months prior to screening with up to 4 weeks screening period, 3 weeks titration phase, 1 week maintenance period, and 1 week follow-up after the last investigational medicinal product administration.

or

  • up to 11 weeks for patients with previous coronary artery angiography or CCTA between 24 months and 5 years prior to screening, who need CCTA during screening period with up to 6 weeks screening period, 3 weeks titration phase, 1 week maintenance period, and 1 week follow-up after the last investigational medicinal product administration.

Clinical Study Identifier: NCT03236311

Contact Investigators or Research Sites near you

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Investigational Site Number 8400013

Wellington, FL United States

Investigational Site Number 8400004

Rochester, MN United States

Investigational Site Number 8400010

Philadelphia, PA United States

Investigational Site Number 4100002

Seoul, Korea, Republic of

Investigational Site Number 5280001

Nijmegen, Netherlands

Investigational Site Number 8400001

Jacksonville, FL United States

Investigational Site Number 8400003

Los Angeles, CA United States

Investigational Site Number 8400012

Atlanta, GA United States

Investigational Site Number 8400008

Baltimore, MD United States

Investigational Site Number 8400006

Boston, MA United States

Investigational Site Number 8400009

New Haven, CT United States

Investigational Site Number 4100003

Seoul, Korea, Republic of

Investigational Site Number 2080001

København Nv, Denmark

Recruitment Status: Closed


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