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NCT01968980 · ClinicalTrials.gov registry record · Phase 3
A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia
A Phase 3 study of Heterozygous Familial Hypercholesterolemia, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 370
- Enrollment target
- 20
- Study locations
NCT01968980: Completed Phase 3 study of Heterozygous Familial Hypercholesterolemia, sponsored by Pfizer.
NCT01968980 is a Phase 3 study of Heterozygous Familial Hypercholesterolemia that has completed, run by Pfizer. The registered enrollment target is 370 participants, above the 171-participant average among 4 other Heterozygous Familial Hypercholesterolemia trials with a reported enrollment target (116% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01968980, a Phase 3 study of Heterozygous Familial Hypercholesterolemia, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 370 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Bococizumab (PF-04950615;RN316)
Study Locations (20)
Florida
- Best Quality Research, Inc. - Hialeah
- Medical Research Center - Miami
- Premier Research Associate, Inc - Miami
- Columbus Clinical Services, LLC - Miami
- NewPhase Clinical Trials, Corp. - Miami Beach
Texas
- Galenos Research - Dallas
- UT Southwestern Medical Center - Dallas
- Pioneer Research Solutions, Inc. - Houston
- Pioneer Research Solutions, Inc. - Sugar Land
Oklahoma
- Oklahoma Heart Hospital Physicians - Oklahoma City
- Oklahoma Heart Hospital Research Foundation - Oklahoma City
- Oklahoma Heart Hospital - Oklahoma City
North Carolina
- The University of North Carolina at Chapel Hill Center for Heart & Vascular Care - Chapel Hill
- The University of North Carolina Hospitals - Clinical and Translational Research Center Clinic - Chapel Hill
California
- IMD Medical Group - Los Angeles
Connecticut
- Hartford Hospital, JB704 - Hartford
Nevada
- Om Medical - Las Vegas
Ohio
- Metabolic and Atherosclerosis Research Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2013-10-23 |
| Est. Completion | 2016-04-15 |
| Phase | Phase 3 |
What the finished NCT01968980 record still lists
NCT01968980 is an interventional study that assigns participants to a tested intervention. The registered 370 participants enrollment target is mid-sized for trials with a published cap, above the 171-participant average among 4 other Heterozygous Familial Hypercholesterolemia trials with a reported enrollment target (116% higher).
The record links to 1 condition, with Heterozygous Familial Hypercholesterolemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01968980 names 20 study sites across 10 states, led by Florida, Texas, Oklahoma.
Frequently Asked Questions
What is clinical trial NCT01968980 about?
NCT01968980 is a clinical study titled "A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia". This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.
What is the current status of trial NCT01968980?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 370 participants. The study started on 2013-10-23. Estimated completion is 2016-04-15.
What conditions does trial NCT01968980 study?
This clinical trial studies the following conditions: Heterozygous Familial Hypercholesterolemia.
What interventions are being tested in trial NCT01968980?
The interventions under investigation include: Placebo (OTHER), Bococizumab (PF-04950615;RN316) (DRUG).
Who is sponsoring clinical trial NCT01968980?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01968980 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Nevada, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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