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NCT02370784 · ClinicalTrials.gov registry record · Phase 2
Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse Scleroderma
A Phase 2 study, sponsored by Robyn T. Domsic, MD, MPH.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT02370784: Completed Phase 2 study, sponsored by Robyn T. Domsic, MD, MPH.
NCT02370784 is a Phase 2 study that has completed, run by Robyn T. Domsic, MD, MPH. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02370784, a Phase 2 study, has completed, sponsored by Robyn T. Domsic, MD, MPH.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to learn about the effect atorvastatin on blood vessel function and Raynaud symptoms in patients with early diffuse systemic sclerosis. Systemic sclerosis is a disease characterized by blood vessel injury, immune system activation and fibrosis. Blood vessel injury is thought to be important early in the disease. Blood vessel complications of systemic sclerosis include Raynaud phenomena, finger and toe ulcers, and pulmonary hypertension. While atorvastatin reduces cholesterol, it is recognized to have many effects beyond cholesterol reduction. These include improvement of blood vessel function and reduction of fibrosis. We hypothesize that treatment with atorvastatin over 16 weeks will improve blood vessel function and Raynaud symptom in patients with early diffuse systemic sclerosis. We hope that by targeting therapy early in the disease we may delay blood vessel changes and improve Raynaud symptoms.
Primary Outcome
EndoPAT is a proprietary device that assesses digital (microvascular) endothelial function during reactive hyperemia. A probe is placed on both index fingers. After 5 minutes of baseline observation, one arm is occluded for 5 minutes, while the other is not and serves as control. Output is the reactive hyperemia index (RHI), calculated as the post-to-pre occlusion signal ratio in the occluded side, "normalized to the control side and further corrected for baseline vascular tone" per Itamar Medic
Interventions
- DRUG Placebo
- DRUG atorvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-02 |
| Est. Completion | 2019-12-15 |
| Phase | Phase 2 |
What the finished NCT02370784 record still lists
NCT02370784 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02370784 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02370784 about?
NCT02370784 is a clinical study titled "Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse Scleroderma". The purpose of this study is to learn about the effect atorvastatin on blood vessel function and Raynaud symptoms in patients with early diffuse systemic sclerosis. Systemic sclerosis is a disease characterized by blood vessel injury, immune system activation and fibrosis. Blood vessel injury is th...
What is the current status of trial NCT02370784?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2015-02. Estimated completion is 2019-12-15.
What interventions are being tested in trial NCT02370784?
The interventions under investigation include: Placebo (DRUG), atorvastatin (DRUG).
Who is sponsoring clinical trial NCT02370784?
This trial is sponsored by Robyn T. Domsic, MD, MPH, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02370784's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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