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

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

November 18, 2015

Primary Completion Date

May 18, 2016

Study Completion Date

August 11, 2016

Conditions
Coronary Artery Disease
Interventions
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

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

Trial Locations (6)

13353

Berlin

20251

Hamburg

42283

Wuppertal

53105

Bonn

69120

Heidelberg

99084

Erfurt

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Bayer

INDUSTRY

NCT02617550 - Vericiguat Drug-drug Interaction With Nitroglycerin in Stable Coronary Artery Disease Patients | Biotech Hunter | Biotech Hunter