A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

346

Participants

Timeline

Start Date

January 24, 2018

Primary Completion Date

August 18, 2018

Study Completion Date

September 18, 2018

Conditions
Stable Coronary Artery Disease
Interventions
DRUG

Selatogrel

Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) or matching placebo will be reconstituted with 1 mL of water for injection. Further dilution with 1 mL sodium chloride (NaCl) 0.9% will be performed for preparation of the dose of 8 mg selatogrel.

DRUG

Placebo

Matching placebo for subcutaneous administration.

DRUG

Selatogrel

Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water for injection.

Trial Locations (20)

2100

Rigshospitalet, Copenhagen

8200

Aarhus University Hospital, Aarhus

10029

Mount Sinai Hospital (New York), New York

18288

Uppsala University Hospital, Uppsala

21093

Inova Cardiology, Lutherville

22042

Inova Center for Thrombosis Research and Translational Medicine, Falls Church

32209

University of Florida (UF) Jacksonville, Jacksonville

33613

Florida Hospital Tampa - Pepin Heart Institute, Tampa

40530

Sahlgrenska University Hospital, Gothenburg

46202

Indiana University School of Medicine - Krannert Institute of Cardiology, Indianapolis

73104

NorthShore University, Chicago

79189

Universitats-Herzzentrum, Bad Krozingen

169609

National Heart Centre Singapore, Singapore

H1T 1C8

Institut de Cardiologie de Montréal, Montreal

9713 GZ

University Medical Center Groningen, Groningen

6229 HX

Maastricht UMC, Maastricht

3435 CM

St. Antonius Ziekenhuis, Nieuwegein

NE7 7DN

Freeman Hospital - Cardiothoracic Department, Newcastle upon Tyne

S5 7AU

Sheffield Teaching Hospitals, Sheffield

SG14AB

East & North Hertfordshire NHS Trust - Lister Hospital, Stevenage

All Listed Sponsors
lead

Viatris Innovation GmbH

INDUSTRY

NCT03384966 - A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease | Biotech Hunter | Biotech Hunter