Clinical Trial Details
| Trial ID: | L4242 |
| Source ID: | NCT03462017 |
| Associated Drug: | Sar247799 |
| Title: | Pharmacodynamic Study to Assess the Effects of Repeated Dosing of SAR247799 on Endothelial Function in Patients With Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Microvascular Coronary Artery Disease |
| Interventions: | DRUG: SAR247799|DRUG: Placebo|DRUG: Sildenafil|DRUG: Acetylcholine |
| Outcome Measures: | Primary: Change in Flow Mediated Dilation (FMD), Absolute change from baseline in the % FMD index of the brachial artery, Baseline to Days 14, 21, 28, 35, and 42 | Secondary: Microvascular reactivity, Change from baseline in peak flow induced by acetylcholine iontophoresis measured using Laser Doppler perfusion monitoring, Baseline to Days 14, 21, 28, 35, and 42|Number of adverse events, Number of participants with adverse events, Up to Day 42|Assessment of pharmacokinetic (PK) parameter: Cmax, Cmax: Maximum plasma concentration observed, Days 1, 2, 3, 7, and 14|Assessment of PK parameter: Ctrough, Ctrough: Plasma concentration observed just before treatment administration during repeated dosing, Days 1, 2, 3, 7, and 14|Assessment of PK parameter: tmax, tmax: Time to reach Cmax, Days 1, 2, 3, 7, and 14|Assessment of PK parameter: AUC0-24, AUC0-24: Area under the plasma concentration versus time curve over the dosing interval (24h), Days 1, 2, 3, 7, and 14 |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 54 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE |
| Start Date: | 2018-03-07 |
| Completion Date: | 2018-12-22 |
| Results First Posted: | |
| Last Update Posted: | 2022-04-25 |
| Locations: | Investigational Site Number 2760002, Mainz, 55116, Germany|Investigational Site Number 2760001, Neuss, 41460, Germany |
| URL: | https://clinicaltrials.gov/show/NCT03462017 |
