Trials / Completed
CompletedNCT03255512
Vericiguat Drug-drug Interaction Study With Isosorbite Mononitrate in Stable Coronary Artery Disease Patients
Multi-center, Randomized, Placebo-controlled, Double-blind Group Comparison Study to Investigate Safety, Tolerability and Blood Pressure of 2.5 mg, 5.0 mg and 10 mg Vericiguat Each Given Over 14 ± 3 Days Together With Isosorbite Mononitrate (ISMN) 60 mg Extended Release Formulation After a Pretreatment Phase (ISMN-starting Dose: 30 mg) in Stable Coronary Artery Disease (CAD) Patients With or Without Heart Failure Aged 30 to 80 Years - Vericiguat ISOsoRbite Mononitrate Interaction (VISOR) Study
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 30 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study is intended to investigate the pharmacodynamic drug-drug interaction as well as the safety and tolerability of isosorbite mononitrate and vericiguat in patients with stable coronary artery disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vericiguat (BAY1021189) | 2.5 mg/tablet; 5 mg/tablet or 10 mg/tablet |
| DRUG | Placebo | Matching placebo |
| DRUG | Isosorbide mononitrate (ISMN) | 30 mg/tablet or 60 mg/tablet |
Timeline
- Start date
- 2017-08-17
- Primary completion
- 2018-02-07
- Completion
- 2018-03-23
- First posted
- 2017-08-21
- Last updated
- 2021-12-29
Locations
6 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03255512. Inclusion in this directory is not an endorsement.