Vericiguat Drug-drug Interaction With Nitroglycerin in Stable Coronary Artery Disease Patients

Phase 1

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Vericiguat (BAY1021189); Drug: Placebo; Drug: Nitroglycerin

• Registration Number: NCT02617550
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-11
• Study Start: 2015-11-18
• Study First Submitted QC: 2015-11-26
• Study First Posted: 2015-12-01
• Primary Completion: 2016-05-18
• Study Completion: 2016-08-11
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vericiguat + Nitroglycerin	Vericiguat (BAY1021189)	Co-administration of vericiguat and nitroglycerin
Vericiguat + Nitroglycerin	Nitroglycerin	Co-administration of vericiguat and nitroglycerin
Placebo + Nitroglycerin	Placebo	Aministration of matching placebo and nitroglycerin.
Placebo + Nitroglycerin	Nitroglycerin	Aministration of matching placebo and nitroglycerin.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events as measure of safety and tolerability	approximately 1 year

Secondary Outcome Measures

Name	Time	Method
Blood pressure	approximately 1 year	Regular measurement of blood pressure (mmHg) in supine, sitting and standing position.
Heart rate	approximately 1 year	Regular measurement of heart rate (bpm) in supine, sitting and standing position.