NCT03236311

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

A Randomized, Double-blind, Placebo-controlled Parallel Arm Dose Titration Study to Assess the Effects of SAR407899 in Patients With Microvascular Angina (MVA) and/or Persistent Stable Angina Despite Angiographically Successful Percutaneous Coronary Intervention (PCI)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Microvascular Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	SAR407899	Pharmaceutical form: Capsule Route of administration: Oral
DRUG	Placebo	Pharmaceutical form: Capsule Route of administration: Oral
DRUG	Adenosine	Pharmaceutical form: Solution for injection Route of administration: Intravenous
DRUG	Regadenoson	Pharmaceutical form: Solution for injection Route of administration: Intravenous
DRUG	13N-ammonia	Pharmaceutical form: Solution for injection Route of administration: Intravenous
DRUG	82Rubidium	Pharmaceutical form: Solution for injection Route of administration: Intravenous

Timeline

• Start date: 2017-10-12
• Primary completion: 2018-07-23
• Completion: 2018-07-23
• First posted: 2017-08-01
• Last updated: 2022-03-24
• Results posted: 2019-07-11

Locations

10 sites across 5 countries: United States, Denmark, Netherlands, South Korea, Sweden

Regulatory

• FDA-regulated drug study