NCT02617550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 coronary-artery-disease

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_1 coronary-artery-disease

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

November 18, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2016

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

November 11, 2015

Last Update Submit

December 9, 2021

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

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

    approximately 1 year

Secondary Outcomes (2)

  • Blood pressure

    approximately 1 year

  • Heart rate

    approximately 1 year

Study Arms (2)

Vericiguat + Nitroglycerin

EXPERIMENTAL

Co-administration of vericiguat and nitroglycerin

Drug: Vericiguat (BAY1021189)Drug: Nitroglycerin

Placebo + Nitroglycerin

PLACEBO COMPARATOR

Aministration of matching placebo and nitroglycerin.

Drug: PlaceboDrug: Nitroglycerin

Interventions

Vericiguat (BAY1021189)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

Vericiguat + Nitroglycerin
PlaceboDRUG

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

Placebo + Nitroglycerin
NitroglycerinDRUG

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 + NitroglycerinVericiguat + Nitroglycerin

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Unknown Facility

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Unknown Facility

Wuppertal, North Rhine-Westphalia, 42283, Germany

Location

Unknown Facility

Erfurt, Thuringia, 99084, Germany

Location

Unknown Facility

Berlin, 13353, Germany

Location

Unknown Facility

Hamburg, 20251, Germany

Location

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

vericiguatNitroglycerin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic Chemicals

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2015

First Posted

December 1, 2015

Study Start

November 18, 2015

Primary Completion

May 18, 2016

Study Completion

August 11, 2016

Last Updated

December 29, 2021

Record last verified: 2021-12

Locations

DE(6)