Trial Condition(s):
Coronary artery disease
Vericiguat drug-drug interaction with nitroglycerin in stable coronary artery disease patients (VENICE)
Bayer Identifier:
17849
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
This study is intended to investigate the effect of nitroglycerin on vericiguat in patients with stable coronary artery disease (CAD). Nitroglycerin is the standard therapy to treat acute crisis of angina. Thus there is a high likelihood of co-administration of both drugs in the target indication of vericiguat, worsening heart failure (HF). Therefore, it is important to investigate the safety and tolerability of vericiguat and nitroglycerin, which may be used as unprescribed on-demand treatment by patients with acute episodes of angina pectoris.
Inclusion Criteria
Patients with stable CAD defined by - coronary artery stenosis in any of the 3 main coronary vessels > 50% documented by coronary angiography within last 36 months or history of myocardial infarction - Age: 30 to 80 years - Body mass index (BMI): above/equal 18.0 and below/equal 36.0 kg / m² - Female subjects must be of non-childbearing potential
Exclusion Criteria
- Intervention e.g. revascularization by percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) during the last 3 months - Progressive angina with symptoms of worsening of angina within the < 3 months - History of recent (< 6 months prior to the first screening examination) myocardial infarction or unstable angina - Symptomatic carotid stenosis, or transient ischemic attack or stroke within 3 months prior or patients with stroke at more than 3 months prior with significant residual neurologic involvement - Insulin dependent diabetes mellitus - Clinically relevant cardiac ischemia - Clinical significant persistent ischemia - Atrial fibrillation, pacemaker, defibrillator, atrial ventricular (AV)-block II and III - Systolic blood pressure below 110 or above 160 mmHg - Diastolic blood pressure above 100 mmHg - Heart rate below 50 or above 100 beats / min - Estimated glomerular filtration rate < 30 mL/min/1.73m2
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Bonn, Germany, 53105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wuppertal, Germany, 42283 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20251 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Erfurt, Germany, 99084 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Evaluation of the effect of 0.4 mg nitroglycerin spray after pretreatment with multiple once daily oral doses of 2.5 mg, 5 mg and 10 mg vericiguat (BAY 1021189) each given over 14 ± 3 days on safety, tolerability and blood pressure in a multi-center, randomized, placebo-controlled, double-blind group comparison study in stable coronary artery disease (CAD) patients aged 30 to 80 years
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Number of participants with adverse events as measure of safety and tolerabilityTimeframe: approximately 1 year
Secondary Outcome
- Blood pressureRegular measurement of blood pressure (mmHg) in supine, sitting and standing position.Timeframe: approximately 1 year
- Heart rateRegular measurement of heart rate (bpm) in supine, sitting and standing position.Timeframe: approximately 1 year
Additional Information
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