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NCT01785615 · ClinicalTrials.gov registry record · Phase 1
Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin
A Phase 1 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
NCT01785615: Completed Phase 1 study, sponsored by University of Rochester.
NCT01785615 is a Phase 1 study that has completed, run by University of Rochester. The registered enrollment target is 116 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01785615, a Phase 1 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
Study Summary
Little is known regarding the association of individual components of the metabolic syndrome (MBS) and prothrombotic, inflammatory and preclinical cardiac structural and functional markers in women with this syndrome. Less is known about adequate treatment as the pathological mechanism of this syndrome is not well understood. The purpose of this study is two fold; 1. To determine basic differences in biochemical and cardiovascular structural markers in women with and those without MBS and their association with the individual components of MBS. 2. To determine the impact of atorvastatin to lower the risk factors of Metabolic Syndrome. Atorvastatin is one of the most effective drugs approved by the United States Food and Drug Administration (FDA) for the treatment of high cholesterol. It belongs to a class of drugs called statins and its role in primary prevention is still unclear. Thus this population seems to be an ideal group that may benefit from this intervention.
Primary Outcome
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.
Interventions
- OTHER Placebo
- DRUG Atorvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2004-11 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT01785615 record still lists
NCT01785615 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01785615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01785615 about?
NCT01785615 is a clinical study titled "Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin". Little is known regarding the association of individual components of the metabolic syndrome (MBS) and prothrombotic, inflammatory and preclinical cardiac structural and functional markers in women with this syndrome. Less is known about adequate treatment as the pathological mechanism of this syndr...
What is the current status of trial NCT01785615?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2004-11. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01785615?
The interventions under investigation include: Placebo (OTHER), Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT01785615?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01785615's enrollment target sits among peer trials
116 501st of 2000 higher than 1,497 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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