check_circleStudy 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
  • 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

  • - 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
36
Trial Dates
November 2015 - August 2016
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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
    date_rangeTime Frame:
    approximately 1 year
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Blood pressure
    Regular measurement of blood pressure (mmHg) in supine, sitting and standing position.
    date_rangeTime Frame:
    approximately 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Heart rate
    Regular measurement of heart rate (bpm) in supine, sitting and standing position.
    date_rangeTime Frame:
    approximately 1 year
    enhanced_encryption
    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
2

Additional Information

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