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

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ClinicalTrials.gov Identifier: NCT02617550
Recruitment Status : Completed
First Posted : December 1, 2015
Last Update Posted : August 24, 2016
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Vericiguat (BAY1021189) Drug: Placebo Drug: Nitroglycerin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : August 2016

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Arm Intervention/treatment
Experimental: Vericiguat + Nitroglycerin
Co-administration of vericiguat and nitroglycerin
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

Drug: 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

Placebo Comparator: Placebo + Nitroglycerin
Aministration of matching placebo and nitroglycerin.
Drug: Placebo
Placebo for 14 +/-3 days given as 1 or 2 tablets [o.d.].

Drug: 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




Primary Outcome Measures :
  1. Number of participants with adverse events as measure of safety and tolerability [ Time Frame: approximately 1 year ]

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: approximately 1 year ]
    Regular measurement of blood pressure (mmHg) in supine, sitting and standing position.

  2. Heart rate [ Time Frame: approximately 1 year ]
    Regular measurement of heart rate (bpm) in supine, sitting and standing position.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617550


Locations
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Germany
Heidelberg, Baden-Württemberg, Germany, 69120
Bonn, Nordrhein-Westfalen, Germany, 53105
Wuppertal, Nordrhein-Westfalen, Germany, 42113
Wuppertal, Nordrhein-Westfalen, Germany, 42283
Erfurt, Thüringen, Germany, 99084
Berlin, Germany, 13353
Hamburg, Germany, 20251
Sponsors and Collaborators
Bayer
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02617550    
Other Study ID Numbers: 17849
2015-001444-11 ( EudraCT Number )
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Nitroglycerin
Vasodilator Agents