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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03236311
Recruitment Status : Terminated ((Recruitment was early terminated due to slow recruitment. Not linked to any safety concern.))
First Posted : August 1, 2017
Results First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Microvascular Coronary Artery Disease
Interventions Drug: SAR407899
Drug: Placebo
Drug: Adenosine
Drug: Regadenoson
Drug: 13N-ammonia
Drug: 82Rubidium
Enrollment 10
Recruitment Details The study was conducted in United States, South Korea, Sweden, Netherlands and Denmark from 12 Oct 2017 to 23 Jul 2018.
Pre-assignment Details A total of 10 participants who met all of the inclusion criteria and none of the exclusion criteria were randomized and enrolled in the study.
Arm/Group Title Placebo SAR407899
Hide Arm/Group Description Matching placebo for 4 weeks. SAR407899 with dose titration over 4 weeks administration (3 week titration phase + 1 week maintenance phase).
Period Title: Overall Study
Started 5 5
Completed 5 2
Not Completed 0 3
Reason Not Completed
Study terminated by sponsor             0             2
Adverse Event             0             1
Arm/Group Title Placebo SAR407899 Total
Hide Arm/Group Description Matching placebo for 4 weeks. SAR407899 with dose titration over 4 weeks administration (3 week titration phase + 1 week maintenance phase). Total of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
Analysis was performed on Randomized population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
64.8  (9.3) 57.2  (8.5) 61.0  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
4
  80.0%
4
  80.0%
8
  80.0%
Male
1
  20.0%
1
  20.0%
2
  20.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  20.0%
0
   0.0%
1
  10.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
4
  80.0%
5
 100.0%
9
  90.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline in Uncorrected Global Coronary Flow Reserve (CFR) at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo SAR407899
Hide Arm/Group Description:
Matching placebo for 4 weeks.
SAR407899 with dose titration over 4 weeks administration (3 week titration phase + 1 week maintenance phase).
Overall Number of Participants Analyzed 4 2
Mean (Standard Deviation)
Unit of Measure: ratio
0.5  (0.6) 0.2  (0.7)
2.Secondary Outcome
Title Change From Baseline in Angina-induced Physical Limitation Assessed Using Seattle Angina Questionnaire Physical Limitation Scale (SAQ-PL) at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
As the number of participants randomized fell well below target (10 vs. 78), hence no data was collected and no analysis was performed.
Arm/Group Title Placebo SAR407899
Hide Arm/Group Description:
Matching placebo for 4 weeks.
SAR407899 with dose titration over 4 weeks administration (3 week titration phase + 1 week maintenance phase).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Pharmacokinetic Parameter: SAR407899 Plasma Concentration
Hide Description [Not Specified]
Time Frame Day 1, 8, 15, 22, and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
As the number of participants randomized fell well below target (10 vs. 78), hence no data was collected and no analysis was performed.
Arm/Group Title Placebo SAR407899
Hide Arm/Group Description:
Matching placebo for 4 weeks.
SAR407899 with dose titration over 4 weeks administration (3 week titration phase + 1 week maintenance phase).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
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)
Adverse Event Reporting Description Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during ‘the treatment emergent period’ (the time from the first dose of study drug administration up to 7 days after the last dose of study drug administration). Analysis was performed on the safety population which included all randomized participants who received at least one dose or part of a dose of the IMP.
 
Arm/Group Title Placebo SAR407899
Hide Arm/Group Description Matching placebo for 4 weeks. SAR407899 with dose titration over 4 weeks administration (3 week titration phase + 1 week maintenance phase).
All-Cause Mortality
Placebo SAR407899
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/5 (0.00%)    
Hide Serious Adverse Events
Placebo SAR407899
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/5 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo SAR407899
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/5 (80.00%)      5/5 (100.00%)    
Cardiac disorders     
Angina Pectoris  1  0/5 (0.00%)  0 1/5 (20.00%)  2
Ear and labyrinth disorders     
Vertigo  1  1/5 (20.00%)  2 0/5 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain  1  0/5 (0.00%)  0 1/5 (20.00%)  1
Abdominal Pain Lower  1  0/5 (0.00%)  0 1/5 (20.00%)  1
General disorders     
Non-Cardiac Chest Pain  1  1/5 (20.00%)  1 0/5 (0.00%)  0
Infections and infestations     
Hordeolum  1  1/5 (20.00%)  2 0/5 (0.00%)  0
Nasopharyngitis  1  1/5 (20.00%)  1 1/5 (20.00%)  1
Injury, poisoning and procedural complications     
Contusion  1  1/5 (20.00%)  1 0/5 (0.00%)  0
Sports Injury  1  1/5 (20.00%)  1 0/5 (0.00%)  0
Nervous system disorders     
Dizziness  1  2/5 (40.00%)  2 2/5 (40.00%)  5
Dizziness Postural  1  0/5 (0.00%)  0 1/5 (20.00%)  4
Headache  1  1/5 (20.00%)  1 2/5 (40.00%)  2
Migraine  1  0/5 (0.00%)  0 1/5 (20.00%)  2
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/5 (0.00%)  0 1/5 (20.00%)  1
Skin and subcutaneous tissue disorders     
Dermatitis Allergic  1  0/5 (0.00%)  0 1/5 (20.00%)  1
1
Term from vocabulary, MedDra 21.0
Indicates events were collected by systematic assessment
The study was prematurely terminated due to small number of participants entering randomization.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03236311    
Other Study ID Numbers: ACT14656
2016-000629-38
U1111-1182-1709 ( Other Identifier: UTN )
First Submitted: July 24, 2017
First Posted: August 1, 2017
Results First Submitted: June 17, 2019
Results First Posted: July 11, 2019
Last Update Posted: July 11, 2019