NCT03415178 - Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 29, 2018

Primary Completion Date

August 9, 2018

Study Completion Date

August 9, 2018

Conditions

Hypercholesterolaemia

Interventions

DRUG

Alirocumab SAR236553

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

DEVICE

Current auto-injector device (AI)

"Pharmaceutical form:~Route of administration: Subcutaneous self-administration of alirocumab"

DEVICE

New auto-injector device (SYDNEY)

"Pharmaceutical form:~Route of administration: Subcutaneous self-administration of alirocumab"

DRUG

Atorvastatin

Pharmaceutical form:tablet Route of administration: oral

DRUG

Rosuvastatin

Pharmaceutical form:tablet Route of administration: oral

Trial Locations (13)

23227

Investigational Site Number 8400005, Richmond

29485

Investigational Site Number 8400022, Summerville

32081

Investigational Site Number 8400013, Ponte Vedra

32216

Investigational Site Number 8400007, Jacksonville

32223

Investigational Site Number 8400017, Jacksonville

33449

Investigational Site Number 8400014, Wellington

45201

Investigational Site Number 8400006, Cincinnati

45219

Investigational Site Number 8400010, Cincinnati

50266

Investigational Site Number 8400001, West Des Moines

54220

Investigational Site Number 8400027, Manitowoc

66606

Investigational Site Number 8400019, Topeka

79106

Investigational Site Number 8400026, Amarillo

90057

Investigational Site Number 8400024, Los Angeles