A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins

PHASE2CompletedINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

February 29, 2012

Study Completion Date

June 30, 2012

Conditions
HypercholesterolemiaDyslipidemia
Interventions
BIOLOGICAL

Placebo

Intravenous placebo monthly during treatment phase.

DRUG

Statin

Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.

BIOLOGICAL

PF-04950615 (RN316)

Intravenous 10mg/mL based on weight monthly during treatment phase.

DRUG

Statin

Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.

BIOLOGICAL

PF-04950615 (RN316)

Intravenous 10mg/mL based on weight monthly during treatment phase.

DRUG

Statin

Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.

BIOLOGICAL

PF-04950615 (RN316)

Intravenous 10mg/mL based on weight monthly during treatment phase.

DRUG

Satin

Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.

BIOLOGICAL

PF-04950615 (RN316)

Intravenous 10mg/mL based on weight monthly during treatment phase.

DRUG

Statin

Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.

Trial Locations (44)

16635

Altoona Center for Clinical Research, Duncansville

19104

Perelman Center for Advanced Medicine, Philadelphia

Translational Research Center, Philadelphia

23294

National Clinical Research - Richmond, Inc., Richmond

23502

National Clinical Research - Norfolk, Inc., Norfolk

27607

North Carolina Clinical Research, Raleigh

28144

PMG Research of Salisbury, Salisbury

29303

Spartanburg Medical Research, Spartanburg

30189

North Georgia Clinical Research, Woodstock

North Georgia Internal Medicine, Woodstock

32216

Jacksonville Center for Clinical Research, Jacksonville

32720

Avail Clinical Research, LLC, DeLand

33166

In Vivo Clinical Research, Inc., Doral

33185

Kendall South Medical Center, Miami

33756

Innovative Research of West Florida, Inc., Clearwater

37920

New Orleans Center for Clinical Research, Knoxville

Volunteer Research Group, Knoxville

40213

L-MARC Research Center, Louisville

42431

Commonwealth Biomedical Research, LLC, Madisonville

63117

Medex Healthcare Research, Inc., St Louis

64111

Saint Luke's Hospital, Kansas City

Saint Luke's Lipid and Diabetes Research Center, Kansas City

64114

The Center for Pharmaceutical Research, P.C., Kansas City

66212

Vince and Associates Clinical Research, Overland Park

67207

Heartland Research Associates, LLC, Wichita

73112

Lynn Health Science Institute, Oklahoma City

73120

Oklahoma Cardiovascular Research Group (OCRG), Oklahoma City

Oklahoma Heart Hospital Physicians, Oklahoma City

Oklahoma Heart Hospital, Oklahoma City

77081

Texas Center for Drug Development, Inc., Houston

78205

Paragon Research Center, LLC, San Antonio

78229

Clinical Trials of Texas, Inc., San Antonio

San Antonio Preventive & Diagnostic Medicine, PA, San Antonio

87106

New Mexico Clinical Research & Osteoporosis Center, Incorporated, Albuquerque

92780

Orange County Research Center, Tustin

94598

Diablo Clinical Research, Inc., Walnut Creek

04210

Maine Research Associates, Auburn

02747

Infinity Medical Research, North Dartmouth

V1Y 3G8

The Medical Arts Health Research Group, Kelowna

G7H 7Y8

Q & T Research Chicoutimi, Chicoutimi

H7T 2P5

Centre de Recherche Clinique de Laval, Laval

H4N 3C5

Diex Research Montreal Inc., Montreal

G1V 4M6

Clinique des Maladies Lipidiques de Quebec Inc., Québec

J1H 1Z1

Diex Research Sherbrooke Inc., Sherbrooke

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01342211 - A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins | Biotech Hunter | Biotech Hunter