A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins
NCT01350141
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- Body Mass Index (BMI) of 18.5 to 40 kg/m2
- On a stable maximum daily dose of a statin, defined as atorvastatin 80 mg or rosuvastatin 40 mg for a minimum of 45 days prior to Day 1.
- Lipids meet the following criteria twice during screening period:
- Fasting LDL C = or > 80 mg/dL;
- Fasting TG < 400 mg/dL.
- History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke,
TIA, angioplasty) during the past year.
- Poorly controlled type 1 or type 2 diabetes mellitus.
- Poorly controlled hypertension.
- Fasting triglycerides > 400 mg/dL
- 12 lead ECG demonstrating QTcFF >455 msec at screening.
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Descriptive Information | ||||
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Brief Title ICMJE | A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins | |||
Official Title ICMJE | A Phase 2, Double-blind, Placebo-controlled, Randomized Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Multiple Intravenous Doses In Hypercholesterolemic Subjects On Maximum Dose Of Atorvastatin Or Rosuvastatin. | |||
Brief Summary | PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 46 | |||
Original Estimated Enrollment ICMJE | 54 | |||
Actual Study Completion Date ICMJE | June 2012 | |||
Actual Primary Completion Date | April 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01350141 | |||
Other Study ID Numbers ICMJE | B1481012 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | October 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |