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NCT03236311

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

Terminated Phase 2 Results posted Last updated 24 March 2022
What this trial tests

Phase 2 trial testing SAR407899 in Microvascular Coronary Artery Disease in 10 participants. Terminated before completion.

Timeline
12 October 2017
Primary endpoint
23 July 2018
23 July 2018

Quick facts

Lead sponsorSanofi
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment10
Start date12 October 2017
Primary completion23 July 2018
Estimated completion23 July 2018
Sites10 locations across Denmark, Netherlands, Sweden, South Korea, United States

Drugs / interventions tested

Conditions studied

Sponsor

Sanofi — full company profile →

Who can join

18 and older, any sex, with Microvascular Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Uncorrected Global Coronary Flow Reserve (CFR) at Week 4 Primary · Baseline, 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.

GroupValue95% CI
Placebo0.5± 0.6
SAR4078990.2± 0.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events (AE) were collected from signature of the informed consent form up to the end of follow up (up to Week 5 post-treatment follow-up visit). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo
Serious: 0/5 (0%)
Deaths: 0/5
SAR407899
Serious: 0/5 (0%)
Deaths: 0/5
Other adverse events (15 terms — click to expand)

ReactionSystemPlaceboSAR407899
DizzinessNervous system disorders
HeadacheNervous system disorders
Angina PectorisCardiac disorders
VertigoEar and labyrinth disorders
Abdominal PainGastrointestinal disorders
Abdominal Pain LowerGastrointestinal disorders
Non-Cardiac Chest PainGeneral disorders
HordeolumInfections and infestations
NasopharyngitisInfections and infestations
ContusionInjury, poisoning and procedural complications
Sports InjuryInjury, poisoning and procedural complications
Dizziness PosturalNervous system disorders
MigraineNervous system disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
Dermatitis AllergicSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT03236311 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Small-Vessel Disease in the Heart and Brain: Current Knowledge, Unmet Therapeutic Need, and Future Directions.
    Berry C, Sidik N, Pereira AC, Ford TJ, et al · · 2019 · cited 81× · PMID 30712442 · DOI 10.1161/jaha.118.011104
  2. Druggable targets in the Rho pathway and their promise for therapeutic control of blood pressure.
    Dee RA, Mangum KD, Bai X, Mack CP, et al · · 2019 · cited 19× · PMID 30189292 · DOI 10.1016/j.pharmthera.2018.09.001

Verify or expand the search:

Other recruiting trials for Microvascular Coronary Artery Disease

Currently open trials in the same condition.

Other Sanofi trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03236311.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing