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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Vericiguat (BAY1021189)
Placebo
Nitroglycerin
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vericiguat + Nitroglycerin

Placebo + Nitroglycerin

Arm Description

Co-administration of vericiguat and nitroglycerin

Aministration of matching placebo and nitroglycerin.

Outcomes

Primary Outcome Measures

Number of participants with adverse events as measure of safety and tolerability

Secondary Outcome Measures

Blood pressure
Regular measurement of blood pressure (mmHg) in supine, sitting and standing position.
Heart rate
Regular measurement of heart rate (bpm) in supine, sitting and standing position.

Full Information

First Posted
November 11, 2015
Last Updated
December 9, 2021
Sponsor
Bayer
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02617550
Brief Title
Vericiguat Drug-drug Interaction With Nitroglycerin in Stable Coronary Artery Disease Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 18, 2015 (Actual)
Primary Completion Date
May 18, 2016 (Actual)
Study Completion Date
August 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vericiguat + Nitroglycerin
Arm Type
Experimental
Arm Description
Co-administration of vericiguat and nitroglycerin
Arm Title
Placebo + Nitroglycerin
Arm Type
Placebo Comparator
Arm Description
Aministration of matching placebo and nitroglycerin.
Intervention Type
Drug
Intervention Name(s)
Vericiguat (BAY1021189)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for 14 +/-3 days given as 1 or 2 tablets [o.d.].
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants with adverse events as measure of safety and tolerability
Time Frame
approximately 1 year
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Regular measurement of blood pressure (mmHg) in supine, sitting and standing position.
Time Frame
approximately 1 year
Title
Heart rate
Description
Regular measurement of heart rate (bpm) in supine, sitting and standing position.
Time Frame
approximately 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53105
Country
Germany
City
Wuppertal
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42283
Country
Germany
City
Erfurt
State/Province
Thüringen
ZIP/Postal Code
99084
Country
Germany
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Hamburg
ZIP/Postal Code
20251
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products.

Learn more about this trial

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

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