Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Authorised, recruiting
Participants planned
88
Countries
1
Sites
1
Degree of control coronary risk factors and platelet aggregation
To analyze the level of systolic blood pressure and LDL-cholesterol in the same patient in 2 different periods: one under treatment of 3 months with the Trinomia® polypill and another of 3 months with the components separately.
Key facts
- Sponsor
- Fundacion Epic
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 27 Mar 2026 → ongoing
- Decision date (initial)
- 2024-11-04
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518705-18-00
- EudraCT number
- 2021-000982-33
- ClinicalTrials.gov
- NCT05030818
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
To analyze the level of systolic blood pressure and LDL-cholesterol in the same patient in 2 different periods: one under treatment of 3 months with the Trinomia® polypill and another of 3 months with the components separately.
Secondary objectives 1
- Total cholesterol and HDL. Diastolic blood pressure level. Patient satisfaction level. Degree of adherence to treatment. Platelet aggregation degree with thromboxane A2 kit. Adverse events.
Conditions and MedDRA coding
Degree of control coronary risk factors and platelet aggregation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10051592 | Acute coronary syndrome | 100000004849 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients over 18 years of age. Patients with ischemic heart disease under treatment with the Trinomia® polypill in any of its presentations for secondary prevention and who can make the 6 visits necessary to complete the study. Patients who sign the Informed Consent.
Exclusion criteria 1
- Patients who do not sign the informed consent. Patients with an inability to understand and comply with the protocol. Patients with contraindication to any component of the polypill. Patients who are already participating in another clinical trial. Patients with any condition that limits life expectancy to <1 year. Patients with programmed coronary revascularization. Patients with coronary stent implantation in the last 12 months. Patients treated with any antithrombotic drug in addition to acetylsalicylic acid, that is, low molecular weight heparin, P2Y12 receptor inhibitors, or oral anticoagulants.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Systolic blood pressure level. LDL cholesterol.
Secondary endpoints 1
- Systolic blood pressure level. LDL cholesterol.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
Trinomia 100 mg/40 mg/10 mg cápsulas duras.
PRD4760731 · Product
- Active substance
- Ramipril
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- C10BX06 — -
- Marketing authorisation
- 81774
- MA holder
- FERRER INTERNACIONAL, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Trinomia 100 mg/40 mg/5 mg cápsulas duras.
PRD4760730 · Product
- Active substance
- Ramipril
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 145 mg milligram(s)
- Max total dose
- 145 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- C10BX06 — -
- Marketing authorisation
- 81773
- MA holder
- FERRER INTERNACIONAL, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Trinomia 100 mg/40 mg/2,5 mg cápsulas duras.
PRD4760729 · Product
- Active substance
- Ramipril
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 142.5 mg milligram(s)
- Max total dose
- 142.5 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- C10BX06 — -
- Marketing authorisation
- 81772
- MA holder
- FERRER INTERNACIONAL, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Trinomia 100 mg/20 mg/10 mg cápsulas duras.
PRD1585984 · Product
- Active substance
- Ramipril
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 130 mg milligram(s)
- Max total dose
- 130 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- C10BX06 — -
- Marketing authorisation
- 78576
- MA holder
- FERRER INTERNACIONAL, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Trinomia 100 mg/20 mg/5 mg cápsulas duras.
PRD1585983 · Product
- Active substance
- Ramipril
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- C10BX06 — -
- Marketing authorisation
- 78575
- MA holder
- FERRER INTERNACIONAL, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Trinomia 100 mg/20 mg/2,5 mg cápsulas duras.
PRD1585982 · Product
- Active substance
- Ramipril
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 122.5 mg milligram(s)
- Max total dose
- 122.5 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- C10BX06 — -
- Marketing authorisation
- 78574
- MA holder
- FERRER INTERNACIONAL, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 6
Cardyl 40 mg comprimidos recubiertos con película
PRD9994593 · Product
- Active substance
- Atorvastatin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AA05 — ATORVASTATIN
- Marketing authorisation
- 61718
- MA holder
- VIATRIS HEALTHCARE LTD
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cardyl 20 mg comprimidos recubiertos con película
PRD9994582 · Product
- Active substance
- Atorvastatin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- C10AA05 — ATORVASTATIN
- Marketing authorisation
- 61717
- MA holder
- VIATRIS HEALTHCARE LTD
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD485274 · Product
- Active substance
- Ramipril
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09AA05 — RAMIPRIL
- Marketing authorisation
- 65104
- MA holder
- SANOFI-AVENTIS, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD485144 · Product
- Active substance
- Ramipril
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09AA05 — RAMIPRIL
- Marketing authorisation
- 59562
- MA holder
- SANOFI-AVENTIS, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD485117 · Product
- Active substance
- Ramipril
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 2.5 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09AA05 — RAMIPRIL
- Marketing authorisation
- 59564
- MA holder
- SANOFI-AVENTIS, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Adiro 100 mg comprimidos gastrorresistentes EFG
PRD450046 · Product
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC06 — ACETYLSALICYLIC ACID
- Marketing authorisation
- 62.825
- MA holder
- BAYER HISPANIA SL
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Epic
- Sponsor organisation
- Fundacion Epic
- Address
- Avenida Condesa Sagasta 10 1c
- City
- Leon
- Postcode
- 24001
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Epic
- Contact name
- Armando Pérez de Prado
Public contact point
- Organisation
- Fundacion Epic
- Contact name
- Armando Pérez de Prado
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruiting | 88 | 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 |
|---|---|---|---|---|---|
| Spain | 2026-03-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 18 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Potocol 2024-518705-18-00_FNP | 1.1 |
| Protocol (for publication) | D1_Potocol 2024-518705-18-00_FP | 1.1 |
| Recruitment arrangements (for publication) | DOCUMENT | 1 |
| Subject information and informed consent form (for publication) | L1_ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC ACOVIL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC ACOVIL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC ACOVIL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC ADIRO | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC CARDYL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC CARDYL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC TRINOMIA 100 20 10 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC TRINOMIA 100 20 2 5 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC TRINOMIA 100 20 5 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC TRINOMIA 100 40 10 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC TRINOMIA 100 40 2 5 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC TRINOMIA 100 40 5 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-518705-18-00 | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-27 | Spain | Acceptable 2024-11-04
|
2024-11-04 |