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.
The total duration of study per participant was: \- up to 9 weeks for participants 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 participants 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
Pharmaceutical form: Capsule Route of administration: Oral
Pharmaceutical form: Capsule Route of administration: Oral
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Pharmaceutical form: Solution for injection Route of administration: Intravenous
Investigational Site Number 8400003
Los Angeles, California, United States
Investigational Site Number 8400001
Jacksonville, Florida, United States
Investigational Site Number 8400013
Wellington, Florida, United States
Investigational Site Number 8400008
Baltimore, Maryland, United States
Investigational Site Number 8400006
Boston, Massachusetts, United States
Investigational Site Number 8400010
Philadelphia, Pennsylvania, United States
Investigational Site Number 2080001
København NV, Denmark
Investigational Site Number 5280001
Nijmegen, Netherlands
Investigational Site Number 4100002
Seoul, South Korea
Investigational Site Number 7520001
Lund, Sweden
Change From Baseline in Uncorrected Global Coronary Flow Reserve (CFR) at Week 4
Absolute change from baseline to Week 4 in uncorrected global CFR, as assessed by the central core laboratory. The global CFR is the ratio of absolute myocardial blood flow (MBF) at stress over that at rest. The MBF was assessed by 13N-ammonia or 82Rubidium positron emission tomography (PET) scan.
Time frame: Baseline, Week 4
Change From Baseline in Angina-induced Physical Limitation Assessed Using Seattle Angina Questionnaire Physical Limitation Scale (SAQ-PL) at Week 4
The SAQ-PL measures how common daily activities representing low, medium, and high exertional requirements were limited by angina (9 items). It was scored by assigning each response an ordinal value, beginning with 1 for the response that implied the 'lowest level of functioning' to 5 for 'not at all limited', and summing across the 9 items. The score of 9 items was then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. The range of scores was 0 to 100, with higher scores indicates better functioning. A change of 10 points was considered to be clinically important.
Time frame: Baseline, Week 4
Pharmacokinetic Parameter: SAR407899 Plasma Concentration
Time frame: Day 1, 8, 15, 22, and Day 29
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