267
Participants
Start Date
August 3, 2021
Primary Completion Date
April 26, 2022
Study Completion Date
June 20, 2022
NNC0385-0434 A 15 mg
15 mg administered as one oral tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces).
NNC0385-0434 A 40 mg
40 mg administered as one oral tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces).
Placebo I A (for NNC0385-0434 A 15 mg)
Placebo administered as 1 tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces). placebo tablets are sized match to the active arm within dose level
NNC0385-0434 A 100 mg
"100 mg administered as one oral tablet once daily in the morning in a fasting state.~The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day.~The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces)."
Placebo I A (for NNC0385-0434 A 40 mg)
"Placebo administered as one tablet once daily in the morning in a fasting state.~The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day.~The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces).~placebo tablets are sized match to the active arm within dose level"
Placebo II A (for NNC0385-0434 A 100 mg)
"Placebo administered as one tablet once daily in the morning in a fasting state.~The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day.~The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces).~placebo tablets are sized match to the active arm within dose level"
Evolocumab 140 mg/mL, Repatha®
"Every 2 weeks subcutaneous (s.c.) injection of 140 mg into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. Administered using a pre-filled SureClick® autoinjector (single-use).~Dose volume: 1 mL"
Jessa Ziekenhuis - Hasselt - Cardiology, Hasselt
Ziekenhuis Oost-Limburg AV - Cardiology, Genk
Hôpital de Jolimont_Haine-Saint-Paul_0, Haine-Saint-Paul
AZ Sint-Jan - Campus Brugge, Bruges
Algemeen Stedelijk Ziekenhuis - Aalst - Interventional Cardiology, Aalst
"Sotiria Thoracic Diseases Hospital of Athens", Athens
Alexandra General Hospital, Therapeutic Clinic, Athens
Albany Medical College - Endo, Albany
"U.G.H of Athens Attikon", Chaidari, Athens
Southgate Medical Group, LLP, West Seneca
"Konstantopouleio G.H. of Athens, Agia Olga", Athens
"Hygeia General Hospital of Athens", Athens
Jacksonville Ctr For Clin Res, Jacksonville
Integrative Research Associates, Inc, Fort Lauderdale
Excel Med Ctr Clinical Trials, Boca Raton
Northwest Heart Clin. Res., Arlington Heights
MVZ CCB Frankfurt Und Main-Taunus GbR, Frankfurt
VA NEB - Western IA Health Stm, Omaha
Univ of Nebraska Medical CTR, Omaha
Louisiana Heart Center, Covington
Louisiana Heart Center_Slidell, Slidell
Thyroid, Endocrinology, and Diabetes, PA, Dallas
PlanIt Research, PLLC, Houston
Jacob, Villingen-Schwenningen, Villingen-Schwenningen
Medical Center - University Of Freiburg, Freiburg im Breisgau
Deutsches Herzzentrum München - Klinik für Herz- und Kreislauferkrankungen, München
"General Hospital of Chios Skilitsio", Chios
Desert Oasis Hlthcr Med Group, Palm Springs
Sanai Hospital, Saitama-shi, Saitama
Shinden Higashi Clinic, Sendai-shi, Miyagi
Soka Sugiura Internal Medicine Clinic, Soka-shi, Saitama
Minamino Cardiovascular Hospital, Tokyo
Jeroen Bosch Ziekenhuis, 's-Hertogenbosch
Deventer Ziekenhuis, Deventer
Martini Ziekenhuis, Groningen
Spaarne Gasthuis, Haarlem
Canisius-Wilhelmina Ziekenhuis, Nijmegen
D & A Research B.V., Sneek
Uniwersyteckie Centrum Kliniczne, Gdansk
Regionalny Osrodek Kardiologii, Lubin
Lubelskie Centrum Diagnostyczne Tomasz Blicharski, Świdnik
Uniwersyteckie Centrum Kliniczne WUM, Warsaw
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o., Warsaw
Narodowy Instytut Kardiologii Stefana kardynała Wyszynskiego, Warsaw
Lead Sponsor
Novo Nordisk A/S
INDUSTRY