Clinical Trial Details
| Trial ID: | L5931 |
| Source ID: | NCT04744636 |
| Associated Drug: | Other |
| Title: | Vascular Function and Biomarker Assessments in Healthy Volunteers and in Patients With Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Other|DRUG: Other |
| Outcome Measures: | Primary: Guanylate triphosphate cyclohydrolase (GTP-CH) investigations, Plasma/platelet levels of Dihydrobiopterin (BAH)/Tetrahydrobiopterin (BH4), Cyclic guanosine monophosphate (cGMP), Day 1|Guanylate triphosphate cyclohydrolase (GTP-CH) investigations, Blood flow changes for vascular endothelial function, Day 1|Guanylate triphosphate cyclohydrolase (GTP-CH) investigations, Coronary flow reserve, Day 2|Guanylate triphosphate cyclohydrolase (GTP-CH) investigations, Genomic market (blood) DNA and/or RNA characteristics of genes such as GTP Cyclohydrolase 1 (GCH), Day 1 | Secondary: Adverse events, Occurence of any adverse events, Through study completion, 3.5 weeks|Blood pressure supine, Relevant abnormalities on supine blood pressure, Day 1 |
| Sponsor/Collaborators: | Sponsor: Institut de Recherches Internationales Servier | Collaborators: ADIR, a Servier Group company |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 100 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER |
| Start Date: | 2017-04-03 |
| Completion Date: | 2018-09-15 |
| Results First Posted: | |
| Last Update Posted: | 2024-07-25 |
| Locations: | Nuvisan GmbH, Neu-Ulm, 89231, Germany |
| URL: | https://clinicaltrials.gov/show/NCT04744636 |
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