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

NCT ID: NCT02617550

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-18

Study Completion Date

2016-08-11

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vericiguat + Nitroglycerin

Co-administration of vericiguat and nitroglycerin

Group Type EXPERIMENTAL

Vericiguat (BAY1021189)

Intervention Type DRUG

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

Nitroglycerin

Intervention Type DRUG

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 + Nitroglycerin

Aministration of matching placebo and nitroglycerin.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for 14 +/-3 days given as 1 or 2 tablets \[o.d.\].

Nitroglycerin

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Placebo

Placebo for 14 +/-3 days given as 1 or 2 tablets \[o.d.\].

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Heidelberg, Baden-Wurttemberg, Germany

Site Status

Bonn, North Rhine-Westphalia, Germany

Site Status

Wuppertal, North Rhine-Westphalia, Germany

Site Status

Erfurt, Thuringia, Germany

Site Status

Berlin, , Germany

Site Status

Hamburg, , Germany

Site Status

Countries

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Germany

Related Links

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http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products.

Other Identifiers

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2015-001444-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17849

Identifier Type: -

Identifier Source: org_study_id