CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
atorvastatin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02370784
NCT02370784Phase 2Completed

The Effect of Atorvastatin on Microvascular Endothelial Function and Raynaud in Early Diffuse Systemic Sclerosis

Robyn T. Domsic, MD, MPH·interventional·Posted Feb 25, 2015·Updated Aug 12, 2020

In Brief

A Phase 2 clinical trial evaluating atorvastatin and Placebo for Scleroderma. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsScleroderma
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 25, 2015
Enrollment StartFeb 1, 2015
Primary CompletionDec 15, 2018
Study CompletionDec 15, 2019
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 11.4 years ago

Interventions

atorvastatindrug

Atorvastatin is an oral cholesterol-lowering medication commonly referred to as statin therapy.

Placebodrug

oral drug of similar appearance to atorvastatin