Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects

PHASE2CompletedINTERVENTIONAL
Enrollment

218

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2015

Conditions
Hypercholesterolemia
Interventions
DRUG

Bococizumab (PF-04950615;RN316)

Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week

DRUG

Bococizumab (PF-04950615;RN316)

Atorvastatin plus PF-04950615 100 mg Q14D SC for 16 week

DRUG

Bococizumab (PF-04950615;RN316)

Atorvastatin plus PF-04950615 150 mg Q14D SC for 16 week

DRUG

Placebo

Atorvastatin plus PF-04950615 Placebo Q14D SC for 16 week

DRUG

Ezetimibe

Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open)

DRUG

Bococizumab (PF-04950615;RN316)

50 mg Q14D SC for 16 week

DRUG

Bococizumab (PF-04950615;RN316)

100 mg Q14D SC for 16 week

DRUG

Bococizumab (PF-04950615;RN316)

150 mg Q14D SC for 16 week

DRUG

Placebo

Placebo Q14D SC for 16 week

Trial Locations (9)

371-0022

Maebashi Hirosegawa Clinic, Maebashi

232-0064

Yokohama Minoru Clinic, Yokohama

565-0853

Heishinkai Medical Group Incorporated OCROM Clinic, Suita

101-0041

Meiwa Hospital, Chiyoda-ku

103-0027

Tokyo-Eki Center-building Clinic, Chuo-ku

160-0022

Heishinkai Medical Group Incorporated ToCROM Clinic, Shinjuku-ku

162-0053

Clinical Research Hospital Tokyo, Shinjuku-ku

169-0072

Oda Clinic, Shinjuku-ku

171-0014

Sekino Hospital, Toshima-ku

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY