Last updated on August 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

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Investigational Site Number 8400013
Wellington, FL United States

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Investigational Site Number 8400004
Rochester, MN United States

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Investigational Site Number 8400010
Philadelphia, PA United States

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Investigational Site Number 4100002
Seoul, Korea, Republic of

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Investigational Site Number 5280001
Nijmegen, Netherlands

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Investigational Site Number 7520001
Lund, Sweden

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Investigational Site Number 8400001
Jacksonville, FL United States

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Investigational Site Number 8400003
Los Angeles, CA United States

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Investigational Site Number 8400012
Atlanta, GA United States

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Investigational Site Number 8400008
Baltimore, MD United States

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Investigational Site Number 8400006
Boston, MA United States

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Investigational Site Number 8400009
New Haven, CT United States

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Investigational Site Number 4100003
Seoul, Korea, Republic of

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Investigational Site Number 2080001
København Nv, Denmark