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NCT01720537 · ClinicalTrials.gov registry record · Phase 1
A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects
A Phase 1 study of Hypercholesterolemia, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 133
- Enrollment target
- 7
- Study locations
NCT01720537: Completed Phase 1 study of Hypercholesterolemia, sponsored by Pfizer.
NCT01720537 is a Phase 1 study of Hypercholesterolemia that has completed, run by Pfizer. The registered enrollment target is 133 participants, below the 815-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (84% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01720537, a Phase 1 study of Hypercholesterolemia, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 133 participants
- Enrollment target
- 7
- Study locations
Study Summary
This study is to evaluate the safety, tolerability and immunogenicity of single, ascending or multiple fixed subcutaneous and intravenous administrations of PF 05335810 to hypercholesterolemic subjects when added on to a daily statin dose.
Primary Outcome
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL PF-05335810 Dose A
- BIOLOGICAL PF-05335810 Dose B
Study Locations (7)
Florida
- Pfizer Investigational Site - Miami
- Pfizer Investigational Site - South Miami
Connecticut
- Pfizer Investigational Site - New Haven
Kansas
- Pfizer Investigational Site - Overland Park
Michigan
- Pfizer Investigational Site - Kalamazoo
Ohio
- Pfizer Investigational Site - Cincinnati
Texas
- Pfizer Investigational Site - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
What the finished NCT01720537 record still lists
NCT01720537 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, below the 815-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Hypercholesterolemia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01720537 lists 7 locations in 6 states (Florida, Connecticut, Kansas).
Frequently Asked Questions
What is clinical trial NCT01720537 about?
NCT01720537 is a clinical study titled "A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects". This study is to evaluate the safety, tolerability and immunogenicity of single, ascending or multiple fixed subcutaneous and intravenous administrations of PF 05335810 to hypercholesterolemic subjects when added on to a daily statin dose.
What is the current status of trial NCT01720537?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 133 participants. The study started on 2012-07. Estimated completion is 2013-10.
What conditions does trial NCT01720537 study?
This clinical trial studies the following conditions: Hypercholesterolemia.
What interventions are being tested in trial NCT01720537?
The interventions under investigation include: Placebo (BIOLOGICAL), PF-05335810 Dose A (BIOLOGICAL), PF-05335810 Dose B (BIOLOGICAL).
Who is sponsoring clinical trial NCT01720537?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01720537 being conducted?
This trial has 7 study locations across Connecticut, Florida, Kansas, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypercholesterolemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01720537's enrollment target sits among peer trials
133 34th of 62 higher than 29 of 62 other Hypercholesterolemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypercholesterolemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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