Clinical trial • Not applicable • Cardiology

ATORVASTATIN for Hyperlipidemia

Not applicable trial of ATORVASTATIN for Hyperlipidemia. 250 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Hyperlipidemia
Trial Stage
Not applicable
Drug Modality
Monoclonal antibody | Small molecule | Oligonucleotide

Key dates

Initial CTIS Submission Date
04-10-2024
First CTIS Authorization Date
10-12-2024

Trial design

Not applicable trial across 1 site in Austria.

Target Sample Size
250

Eligibility

Recruits 250 No vulnerable population selected (isVulnerablePopulationSelected: false). Participants are adults (Age 18–75 years). A subject information and informed consent form document is listed (L1_SIS and ICF); no assent process or other vulnerable-population consent arrangements are specified in the record..

Pregnancy Exclusion
Pregnancy
Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). Participants are adults (Age 18–75 years). A subject information and informed consent form document is listed (L1_SIS and ICF); no assent process or other vulnerable-population consent arrangements are specified in the record.

Inclusion criteria

  • {"criterion_text":"- Inclusion criteria for all cohorts except the new-onset low-dose statin therapy patient group: - Age 18–75 years - LDL cholesterol levels >116 mg/dl - Previously prescribed dyslipidemia treatment according to the ESC/EAS guidelines with either atorvastatin >=40 mg, rosuvastatin >=20 mg or PCSK-9 inhibitors such as Praluent, Repatha or Inclisiran\n- Inclusion criteria for the new-onset low-dose statin therapy patient group: - No history of statin treatment - Age 18–75 years - LDL cholesterol levels >116 mg/dl before statin treatment - Previously prescribed dyslipidemia treatment according to the ESC/EAS guidelines with simvastatin <=20 mg, atorvastatin <=10 mg or rosuvastatin <=10 mg"}

Exclusion criteria

  • {"criterion_text":"- 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 on the feasibility of MR measurements."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Changes in sex steroid levels","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
250
Recruitment Window Months
27
Consent Approach
Informed consent is via a Subject information and informed consent form document (L1_SIS and ICF). Participants are adults (18–75 years) and therefore provide consent themselves; no assent process or specific languages for consent documents are specified in the record.

Geography

Total Number Of Sites
1
Total Number Of Participants
250

Austria

Earliest CTIS Part Ii Submission Date
16-10-2024
Latest Decision Or Authorization Date
10-12-2024
Processing Time Days
55
Number Of Sites
1
Number Of Participants
250

Sites

Site Name
Waehringer Guertel 18-20, Alsergrund
Department Name
Division of Endocrinology and Metabolism, Department of Medicine III
Principal Investigator Name
Alexandra Kautzky-Willer
Principal Investigator Email
alexandra.kautzky-willer@meduniwien.ac.at
Contact Person Name
Alexandra Kautzky-Willer

Sponsor

Primary sponsor

Full Name
Medical University Of Vienna
Organisation Type
Educational Institution
Country Of Registered Address
Austria

Investigational products

Investigational Product Name
ATORVASTATIN
Active Substance
ATORVASTATIN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
80 mg
Investigational Product Name
ALIROCUMAB
Active Substance
ALIROCUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Maximum Dose
300 mg
Investigational Product Name
ROSUVASTATIN
Active Substance
ROSUVASTATIN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
40 mg
Investigational Product Name
EVOLOCUMAB
Active Substance
EVOLOCUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Maximum Dose
140 mg
Investigational Product Name
INCLISIRAN
Active Substance
INCLISIRAN
Modality
Oligonucleotide
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Maximum Dose
284 mg
Investigational Product Name
Praluent 150 mg solution for injection in pre-filled pen
Active Substance
ALIROCUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
EU/1/15/1031/018
Maximum Dose
300 mg
Investigational Product Name
Repatha 140 mg solution for injection in pre-filled syringe
Active Substance
EVOLOCUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
EU/1/15/1016/001
Maximum Dose
140 mg
Investigational Product Name
Leqvio 284 mg solution for injection in pre-filled syringe
Active Substance
INCLISIRAN
Modality
Oligonucleotide
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
EU/1/20/1494/001
Maximum Dose
284 mg
Investigational Product Name
Rosuvastatin 5 mg film-coated tablets
Active Substance
ROSUVASTATIN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
PL 16363/0506
Maximum Dose
40 mg
Investigational Product Name
Atorvastatin 10 mg film-coated tablets
Active Substance
ATORVASTATIN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
PL 43461/0017
Maximum Dose
80 mg

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