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

Coronary Artery Disease Clinical Trial

— VENICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617550
• Other study ID #: 17849
• Secondary ID: 2015-001444-11
• Status: Completed
• Phase: Phase 1
• Start date: November 18, 2015
• Est. completion date: August 11, 2016

Study information

• Verified date: December 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 11, 2016
• Est. primary completion date: May 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Vericiguat (BAY1021189)
Vericiguat up-titration from 2.5 mg to 10 mg in an interval of 14 +/- 3 days: 2.5 mg vericiguat for 14 +/-3 days given as 2 x 1.25 mg tablets followed by 5 mg vericiguat for 14 +/-3 days given as 1 x 5 mg tablet followed by 10 mg vericiguat for 14 +/-3 days given as 2 x 5 mg tablets
• Placebo
Placebo for 14 +/-3 days given as 1 or 2 tablets [o.d.].
• Nitroglycerin
0.4 mg nitroglycerin spray administered at 2.5 hours before treatment (vericiguat [trough] or placebo) on day 12, day 26 and day 40 at 4 hours after treatment (vericiguat [peak] or placebo) on day 13, day 27 and day 41

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as measure of safety and tolerability		approximately 1 year
Secondary	Blood pressure	Regular measurement of blood pressure (mmHg) in supine, sitting and standing position.	approximately 1 year
Secondary	Heart rate	Regular measurement of heart rate (bpm) in supine, sitting and standing position.	approximately 1 year

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