A Phase II, pilot clinical trial to evaluate the effects of atorvastatin on Graves' Orbitopathy (GO) in hypercholesterolemic patients with moderate-to-severe and active GO subjected to intravenous glucocorticoid therapy.

Phase 1

• Conditions: Graves’ orbitopathy is a disabling and disfiguring disease affecting the eyes observed in approximately 25-30% of patients with Graves’ disease. Its clinical manifestations include exophthalmos, inflammatory signs and symptoms, diplopia, and in most severe cases sight impairment.; MedDRA version: 20.0Level: PTClassification code 10004161Term: Basedow's diseaseSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2018-001317-33-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-07
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1)Informed consent ; 2) A diagnosis of Graves’ disease; 3) A moderately severe Graves’ orbitopathy; 4) Active Graves’ orbitopathy; 5) No corticosteroids or immunosuppressive treatment for Graves’ orbitopathy in the last 3 months; 6) No previous surgical treatment for GO; 7) No contraindication to GC; 8) Male and female patients of age: 18-75 years; 9) LDL-cholesterol levels of 115-189 mg/dl; 10) No more than one cardiovascular risk factor; 11) Contraceptive method with a failure rate of less than 1% (patients of childbearing potential); 12) No mental illness ; 13) Compliant patient, regular follow-up possible
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 88
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

1) lack of informed consent; 2) Absence of Graves’ hyperthyroidism; 3) inactive Graves’ orbitopathy; 4) Optic neuropathy; 5) Corticosteroids or immunosuppressive treatment in the last 3 months; 6) Previous surgical treatment for Graves’ orbitopathy; 7) Contraindications to glucocorticoids; 8) Pregnancy, breast-feeding women; 9) Acute or chronic liver disease; 10) Hypersensitivity to atorvastatin or other statins, or hypersensitivity or intolerance to the medication excipients such as lactose; 11) Medications interfering/interacting with statins; 12) Relevant Malignancy; 13) Recent (=1 year) history of alcoholism or drug abuse; 14) Clinical ASCVD (AthroSclerotic CardioVascular Disease); 15) LDL-cholesterol levels =190 mg/dl or presence of more than one associated cardiovascular risk factor;16) Severe familial hyperlipemia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified