Trial · NCT03236311
A Dose Titration Study to Assess the Effects of SAR407899 in Patients With MVA and/or Persistent Stable Angina Despite Angiographically Successful PCI
NCT03236311, Phase 2, Terminated, Sanofi; results first posted 2019-07-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Dose Titration Study to Assess the Effects of SAR407899 in Patients With MVA and/or Persistent Stable Angina Despite Angiographically Successful PCI. Trials, record NCT03236311. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03236311
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose Titration Study to Assess the Effects of SAR407899 in Patients With MVA and/or Persistent Stable Angina Despite Angiographically Successful PCI
- NCT number
- NCT03236311
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Microvascular Coronary Artery Disease
- Interventions
- SAR407899, Placebo, Adenosine, Regadenoson, 13N-ammonia, 82Rubidium
- First posted
- 2017-08-01
- Last updated
- 2022-03-24
- Results first posted
- 2019-07-11
- Limitations and caveats
- The study was prematurely terminated due to small number of participants entering randomization.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Uncorrected Global Coronary Flow Reserve (CFR) at Week 4 | 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. |
| Secondary | Change From Baseline in Angina-induced Physical Limitation Assessed Using Seattle Angina Questionnaire Physical Limitation Scale (SAQ-PL) at Week 4 | Baseline, 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. |
| Secondary | Pharmacokinetic Parameter: SAR407899 Plasma Concentration | Day 1, 8, 15, 22, and Day 29 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Uncorrected Global Coronary Flow Reserve (CFR) at Week 4 | Baseline, Week 4 | Analysis was performed on modified intent-to-treat (mITT) population that included all randomized participants analyzed according to the treatment group allocated by randomization; who received at least 1 dose or part of a dose of the investigational medicinal product (IMP) and with an evaluable primary efficacy endpoint. | ratio | MEAN |
| SECONDARY | Change From Baseline in Angina-induced Physical Limitation Assessed Using Seattle Angina Questionnaire Physical Limitation Scale (SAQ-PL) at Week 4 | Baseline, Week 4 | As the number of participants randomized fell well below target (10 vs. 78), hence no data was collected and no analysis was performed. | ||
| SECONDARY | Pharmacokinetic Parameter: SAR407899 Plasma Concentration | Day 1, 8, 15, 22, and Day 29 | As the number of participants randomized fell well below target (10 vs. 78), hence no data was collected and no analysis was performed. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Uncorrected Global Coronary Flow Reserve (CFR) at Week 4 | Placebo | 0.5 | Standard Deviation 0.6 | ratio | |
| Change From Baseline in Uncorrected Global Coronary Flow Reserve (CFR) at Week 4 | SAR407899 | 0.2 | Standard Deviation 0.7 | ratio |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 5 | |
| Overall Study | STARTED | SAR407899 | 5 | |
| Overall Study | COMPLETED | Placebo | 5 | |
| Overall Study | COMPLETED | SAR407899 | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | SAR407899 | 3 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Angina Pectoris | Cardiac disorders | Placebo | 0 | 5 | 0 |
| other | Angina Pectoris | Cardiac disorders | SAR407899 | 1 | 5 | 2 |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 1 | 5 | 2 |
| other | Vertigo | Ear and labyrinth disorders | SAR407899 | 0 | 5 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 0 | 5 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | SAR407899 | 1 | 5 | 1 |
| other | Abdominal Pain Lower | Gastrointestinal disorders | Placebo | 0 | 5 | 0 |
| other | Abdominal Pain Lower | Gastrointestinal disorders | SAR407899 | 1 | 5 | 1 |
| other | Non-Cardiac Chest Pain | General disorders | Placebo | 1 | 5 | 1 |
| other | Non-Cardiac Chest Pain | General disorders | SAR407899 | 0 | 5 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 5 |
| Total, all-cause mortality | SAR407899 | 0 | 5 |
| Total, other adverse events | Placebo | 4 | 5 |
| Total, other adverse events | SAR407899 | 5 | 5 |
| Total, serious adverse events | Placebo | 0 | 5 |
| Total, serious adverse events | SAR407899 | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SAR407899 vs Placebo: deaths from any cause | Trial comparisons |
| SAR407899 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03236311
GET https://conductscience.org/api/trials/v1/NCT03236311/events?page=2