Cholesterol-lowering drugs and the effect on vital hormones, bile acids, the immune systems and related diseases such as depression or osteoporosis

Phase 1

• Conditions: Patients with a diagnosed hyperlipidemia firstly treated with statins (with either simvastatin <=20mg, atorvastatin <=10mg or rosuvastatin <=10mg - random allocation), or who need an increase of their dosages of their statins with either atorvastatin 80mg or rosuvastatin >=20mg will be investigated. Additionally patients who are treated with a combination therapy of high-dose statins with PCSK-9 inhibitors or treated with a monotherapy with PCSK-9 inhibitors will be investigated.; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2020-001000-42-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-25
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Inclusion criteria for all cohorts except the New-onset low-dose statin therapy patient group:
-Age 18-70 years
-LDL-cholesterol levels >130mg/dl
-Previously prescribed dyslipidemia treatment according to the ESC/EAS guidelines with either atorvastatin 80mg, rosuvastatin >=20mg or PCSK-9 inhibitors such as Praluent or Repatha.

Inclusion criteria for the New-onset low-dose statin therapy patient group:
-No history of statin treatment
-Age 18-70 years
-LDL-cholesterol levels >180mg/dl before statin treatment
-Previously prescribed dyslipidemia treatment according to the ESC/EAS guidelines with simvastatin <=20mg, atorvastatin <=10mg or rosuvastatin <=10mg

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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

-Familiar hypercholesterolemia
-Severe liver disease
-Pregnancy
-Malignant disorders
-Hepatitis B and Hepatitis C
-HIV
-Primary psychiatric disorder other than depression (ICD-10: F32 and F33)
-Exclusion criteria for the MR-investigations: claustrophobia, implants in the human body that do not fit to the guidelines of the feasibility of MR measurements.

Study & Design

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