Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS-APO(a)Rx in Participants With High Lipoprotein(a)

PHASE2CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
Elevated Lipoprotein(a)
Interventions
DRUG

ISIS-APO(a)Rx

ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.

DRUG

Placebo

Normal saline as Placebo, subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.

Trial Locations (13)

2730

Herlev University Hospital, Herlev

13353

Charite - University Hospital Berlin - Campus Virchow - Hospital, Berlin

39120

Otto-von Guericke Universitaet, Uniklinik Magdeburg, Magdeburg

50937

Uniklinik Koeln, Zentrum fuer Endokrinologie, Diabetologie und Praeventivmedizin (ZEDP), Cologne

G7H 5H6

Chicoutimi Hospital, Chicoutimi

G1V4M6

Clinique des Maladies Lipidiques de Quebec Inc., Québec

1105 AZ

University of Amsterdam - Dept. of Vascular Medicine F4-109, Amsterdam

6229 HX

Academic Hospital Maastricht, Maastricht

3045 PM

Sint Franciscus Gasthuis, Rotterdam

3584 CX

University Medical Center Utrecht, Utrecht

B9 5SS

Heart of England NHS Foundation Trust, Birmingham

M20 2RN

Barlow Medical Centre, Manchester

NE1 4LP

Newcastle Upon Tyne Hospitals, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Ionis Pharmaceuticals, Inc.

INDUSTRY