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

NCT03236311 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-03-24

Study results available
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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.

Conditions

  • Microvascular Coronary Artery Disease

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-12
Primary Completion
2018-07-23
Completion
2018-07-23
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Netherlands
  • South Korea
  • Sweden

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03236311 on ClinicalTrials.gov