Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
250
Countries
1
Sites
1
Hyperlipidemia
Do cholesterol-lowering drugs reduce the levels of steroid hormones?
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 10 Dec 2024 → ongoing
- Decision date (initial)
- 2024-12-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516967-10-00
- EudraCT number
- 2020-001000-42
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Do cholesterol-lowering drugs reduce the levels of steroid hormones?
Conditions and MedDRA coding
Hyperlipidemia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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 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 1
- - 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 and secondary outcome measures (English text)
Primary endpoints 1
- Changes in sex steroid levels
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 23
SUB128552 · Substance
- Active substance
- Evolocumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 140 mg milligram(s)
- Max total dose
- 140 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB170596 · Substance
- Active substance
- Alirocumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB170596 · Substance
- Active substance
- Alirocumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20634 · Substance
- Active substance
- Rosuvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20634 · Substance
- Active substance
- Rosuvastatin
- Pharmaceutical form
- TABLETS
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20634 · Substance
- Active substance
- Rosuvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20634 · Substance
- Active substance
- Rosuvastatin
- Pharmaceutical form
- TABLETS
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB182427 · Substance
- Active substance
- Inclisiran
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 284 mg milligram(s)
- Max total dose
- 284 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05600MIG · Substance
- Active substance
- Atorvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05600MIG · Substance
- Active substance
- Atorvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05600MIG · Substance
- Active substance
- Atorvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05600MIG · Substance
- Active substance
- Atorvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05600MIG · Substance
- Active substance
- Atorvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1010304 · ATC
- Active substance
- Atorvastatin
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AA05 — ATORVASTATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP102639772 · ATC
- Active substance
- Rosuvastatin Zinc
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AA07 — ROSUVASTATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP49547845 · ATC
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AX14 — ALIROCUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP18725227 · ATC
- Active substance
- Evolocumab
- Substance synonyms
- AMG145
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 140 mg milligram(s)
- Max total dose
- 140 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AX13 — EVOLOCUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP47421243 · ATC
- Active substance
- Inclisiran
- Substance synonyms
- ALN-60212
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 284 mg milligram(s)
- Max total dose
- 284 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AX16 — INCLISIRAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Rosuvastatin 5 mg film-coated tablets
PRD4310512 · Product
- Active substance
- Rosuvastatin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AA07 — ROSUVASTATIN
- Marketing authorisation
- PL 16363/0506
- MA holder
- MILPHARM LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Atorvastatin 10 mg film-coated tablets
PRD4844875 · Product
- Active substance
- Atorvastatin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AA05 — ATORVASTATIN
- Marketing authorisation
- PL 43461/0017
- MA holder
- FLAMINGO PHARMA UK LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Leqvio 284 mg solution for injection in pre-filled syringe
PRD8574502 · Product
- Active substance
- Inclisiran
- Substance synonyms
- ALN-60212
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 284 mg milligram(s)
- Max total dose
- 284 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AX16 — -
- Marketing authorisation
- EU/1/20/1494/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Repatha 140 mg solution for injection in pre-filled syringe
PRD3018595 · Product
- Active substance
- Evolocumab
- Substance synonyms
- AMG145
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- ORAL
- Max daily dose
- 140 mg milligram(s)
- Max total dose
- 140 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AX13 — -
- Marketing authorisation
- EU/1/15/1016/001
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Praluent 150 mg solution for injection in pre-filled pen
PRD8819941 · Product
- Active substance
- Alirocumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AX14 — -
- Marketing authorisation
- EU/1/15/1031/018
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Spitalgasse 23, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Division of Endocrinology and Metabolism, Department of Medicine III
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Division of Endocrinology and Metabolism, Department of Medicine III
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 250 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-12-10 | 2024-12-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-516967-10-00 | 13.2 |
| Recruitment arrangements (for publication) | Placeholder | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 13.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Atorvastatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Evolocumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Inclisiran | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Praluent | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rosuvastatin | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-04 | Austria | Acceptable 2024-12-06
|
2024-12-10 |