Study Completed

Coronary Artery Disease

Bayer Identifier:

17849

ClinicalTrials.gov Identifier:

NCT02617550

EudraCT Number:

2015-001444-11

EU CT Number:

Not Available

Vericiguat drug-drug interaction with nitroglycerin in stable coronary artery disease patients

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.

Key Participants Requirements

Sex

Both

Age

30 - 80 Years

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

November 2015 - August 2016

Phase

Phase 1

Could I Receive a placebo

Yes

Products

Verquvo (Vericiguat, BAY1021189)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Bonn, 53105, Germany
Completed		Wuppertal, 42283, Germany
Completed		Hamburg, 20251, Germany
Completed		Heidelberg, 69120, Germany
Completed		Berlin, 13353, Germany
Withdrawn		Wuppertal, 42113, Germany
Completed		Erfurt, 99084, Germany

Primary Outcome

Number of participants with adverse events as measure of safety and tolerability
Time Frame:
approximately 1 year
Safety Issue:
Yes

Secondary Outcome

Blood pressure
Regular measurement of blood pressure (mmHg) in supine, sitting and standing position.
Time Frame:
approximately 1 year
Safety Issue:
No
Heart rate
Regular measurement of heart rate (bpm) in supine, sitting and standing position.
Time Frame:
approximately 1 year
Safety Issue:
No

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

Additional Information

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