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COMPLETED Phase 3

A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia

NCT01968980 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 370 participants
Start Date 2013-10-23
Est. Completion 2016-04-15
Phase Phase 3

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01968980

The ClinicalTrials.gov registry entry for NCT01968980 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01968980 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, Texas, Oklahoma. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01968980?

The interventions under investigation include: Placebo (OTHER), Bococizumab (PF-04950615;RN316) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01968980?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial