Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ended
Participants planned
191
Countries
3
Sites
12
Arterial hypertension
To assess efficacy of treatment with single-pill combination (SPC) of telmisartan/amlodipine (T/A) and SPC of telmisartan/amlodipine/hydrochlorothiazide (T/A/HCTZ) on 24-hour blood pressure (BP) reduction after 16 weeks of treatment in patients with Grade 1, Grade 2 or Grade 3 arterial hypertension.
Key facts
- Sponsor
- KRKA tovarna zdravil d.d. Novo mesto
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 6 May 2024 → 24 Aug 2025
- Decision date (initial)
- 2024-01-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To assess efficacy of treatment with single-pill combination (SPC) of telmisartan/amlodipine (T/A) and SPC of telmisartan/amlodipine/hydrochlorothiazide (T/A/HCTZ) on 24-hour blood pressure (BP) reduction after 16 weeks of treatment in patients with Grade 1, Grade 2 or Grade 3 arterial hypertension.
Secondary objectives 1
- To assess efficacy of treatment with SPC of T/A and SPC of T/A/HCTZ on office BP control and on 24-hour BP variability after 16 weeks of treatment in patients with Grade 1, Grade 2 or Grade 3 arterial hypertension.
Conditions and MedDRA coding
Arterial hypertension
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10081425 | Arterial hypertension | 10047065 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Patients with diagnosed Grade 1, Grade 2 or Grade 3 Arterial Hypertension at Visit 1 AND Visit 2.
- Average 24-hour SBP ≥130 mmHg AND/OR average 24-hour DBP ≥80 mmHg, obtained by the ambulatory blood pressure monitoring (ABPM) device at the study baseline.
- Patients who are treatment-naïve OR uncontrolled on: existing antihypertensive monotherapy or dual combinational therapy (except those on telmisartan and amlodipine therapy).
- Female or male patients, aged ≥18 years.
- Patients with ability to adhere to the trial protocol according to the investigator’s judgement
- Patients who have been provided with information about the trial and have voluntarily signed the informed consent.
- Patients who have signed the consent for collection, analysis and processing of personal data, that will be collected during this clinical trial for the purpose of statistical analysis and final report of this clinical trial.
Exclusion criteria 5
- Previous or current antihypertensive therapy with telmisartan and amlodipine taken concomitantly or as single-pill combination.
- Any of the following laboratory or ECG findings: significant anaemia with haemoglobin less than 100 g/L, abnormal values of serum potassium (i.e. hypo- and hyperkalaemia; with reference to the normal laboratory values) that are clinically significant according to the investigator’s judgement, hypercalcaemia (with reference to the normal laboratory values) that is clinically significant according to the investigator’s judgement, atrioventricular (A-V) block grade 2 or 3, ECG signs of acute ischemia.
- Renal impairment – GFR <45 ml/min/1.73 m2 (e.g. bilateral renal artery stenosis, renal artery stenosis in a solitary kidney or post-renal transplant patients, dialysis patients, anuria).
- Concomitant therapy with: pressor amines, lithium, digoxin, aliskiren-containing products, drugs that can provoke hyperkalaemia: potassium supplements, or potassium-containing salt substitutes, drugs that may reduce the antihypertensive effect: systemic corticosteroids.
- Non-compliance with 24-hour BP measurement quality criteria.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Mean absolute change of 24-hour SBP after 16 weeks of treatment (from baseline to Visit 7) with TIMP.
Secondary endpoints 7
- Mean change in average real variability of 24-hour SBP (ARVs) and mean change in average real variability of 24-hour DBP (ARVd) after 16 weeks of treatment (from baseline to Visit 7) with TIMP.
- Mean absolute change of 24-hour DBP after 16 weeks of treatment (from baseline to Visit 7) with TIMP.
- Mean absolute and relative changes of office SBP and DBP after 4, 8, 12 and 16 weeks of treatment (from baseline to Visit 3, Visit 4, Visit 5 and Visit 7, respectively) with TIMP.
- Mean absolute change of the calculated central SBP (cSBP) and calculated central DBP (cDBP) after 16 weeks of treatment (from baseline to Visit 7) with TIMP.
- Mean SI after 16 weeks of treatment (from baseline to Visit 7) with TIMP.
- Mean absolute changes of 24-hour SBP, separately in groups of dipping, extreme dipping and non-dipping patients after 16 weeks of treatment (from baseline to Visit 7) with TIMP.
- Mean absolute change of pulse wave velocity (PWV) after 16 weeks of treatment (from baseline to Visit 7) with TIMP.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 12
Teldipin, 40 mg + 5 mg, tabletki
PRD5837721 · Product
- Active substance
- Amlodipine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 45 mg milligram(s)
- Max total dose
- 2880 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- C09DB04 — -
- Marketing authorisation
- 24127
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD4756408 · Product
- Active substance
- Amlodipine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 85 mg milligram(s)
- Max total dose
- 9520 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- C09DB04 — -
- Marketing authorisation
- H/17/02287/017
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Slovenia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Teldipin, 80 mg + 10 mg, tabletki
PRD5837724 · Product
- Active substance
- Amlodipine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 10080 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- C09DB04 — -
- Marketing authorisation
- 24130
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD4873394 · Product
- Active substance
- Amlodipine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 45 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- C09DB04 — -
- Marketing authorisation
- OGYI-T-23157/02
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Hungary
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Teldipin, 80 mg + 5 mg, tabletki
PRD5837723 · Product
- Active substance
- Amlodipine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 85 mg milligram(s)
- Max total dose
- 5440 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- C09DB04 — -
- Marketing authorisation
- 24129
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD4873412 · Product
- Active substance
- Amlodipine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 85 mg milligram(s)
- Max total dose
- 9520 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- C09DB04 — -
- Marketing authorisation
- OGYI-T-23157/20
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Hungary
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD4756416 · Product
- Active substance
- Amlodipine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 10080 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- C09DB04 — -
- Marketing authorisation
- H/17/02287/025
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Slovenia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD4756392 · Product
- Active substance
- Amlodipine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 45 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- C09DB04 — -
- Marketing authorisation
- H/17/02287/001
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Slovenia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD4873421 · Product
- Active substance
- Amlodipine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 10080 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- C09DB04 — -
- Marketing authorisation
- OGYI-T-23157/29
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Hungary
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Telmisartan/Amlodipine/Hydrochlorothiazide
PRD10644635 · Product
- Active substance
- Amlodipine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 97.5 mg milligram(s)
- Max total dose
- 10920 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- C09DX08 — -
- MA holder
- KRKA, D. D., NOVO MESTO
- Paediatric formulation
- No
- Orphan designation
- No
Telmisartan/Amlodipine/Hydrochlorothiazide
PRD10644633 · Product
- Active substance
- Amlodipine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 102.5 mg milligram(s)
- Max total dose
- 11480 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- C09DX08 — -
- MA holder
- KRKA, D. D., NOVO MESTO
- Paediatric formulation
- No
- Orphan designation
- No
Telmisartan/Amlodipine/Hydrochlorothiazide
PRD10644634 · Product
- Active substance
- Amlodipine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 115 mg milligram(s)
- Max total dose
- 12880 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- C09DX08 — -
- MA holder
- KRKA, D. D., NOVO MESTO
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
KRKA tovarna zdravil d.d. Novo mesto
- Sponsor organisation
- KRKA tovarna zdravil d.d. Novo mesto
- Address
- Smarjeska Cesta 6
- City
- Novo Mesto
- Postcode
- 8000
- Country
- Slovenia
Scientific contact point
- Organisation
- KRKA tovarna zdravil d.d. Novo mesto
- Contact name
- Breda Barbič-Žagar
Public contact point
- Organisation
- KRKA tovarna zdravil d.d. Novo mesto
- Contact name
- Breda Barbič-Žagar
Locations
3 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 40 | 3 |
| Poland | Ended | 50 | 6 |
| Slovenia | Ended | 20 | 3 |
| Rest of world
Armenia
|
— | 81 | — |
Investigational sites
Egészségedre Kft.
GP office, Tulipán u. 40, H-6900, Makó
Vitalmed 2003 Bt.
GP office, Fo Utca 42, 4066, Tiszacsege
Biatros Kft.
GP office, Tancsics Mihaly Utca 1, 2051, Biatorbagy
B&R Clinical Sp. z o.o.
Cardiology, Ul. Marii Opielinskiej 16b, 25-426, Kielce
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lecznej
Cardiology, Ul. Krasnystawska 52, 21-010, Leczna
Medicome Sp. z o.o.
Cardiology, Plac Tadeusza Kosciuszki 12, 32-600, Oswiecim
Niepubliczny Zakład Opieki Zdrowotnej Medicus S. C.
General practice, ul. Jelenia 30A, Poland, Podkowa Leśna
Md Clinic Sp. z o.o.
Cardiology, Ul. Sienna 83/189, 00-815, Warsaw
Policlinica Centrum Sp. z o.o.
Cardiology, Ul. Stefana Batorego 7, 81-366, Gdynia
MC MEDICOR mednarodni center za kardiovaskularne bolezni d.d.
Private internistical (cardiology) centre/clinic, Kotnikova Ulica 5, 1000, Ljubljana
Splosna Bolnisnica Jesenice
General hospital of Jesenice (internal medicine department), Cesta Marsala Tita 112, 4270, Jesenice
Verboten Kopriva Renata Ordinacija Interne Medicine
Internal medicine private practice/clinic, Partizanska Pot 8a, 1270, Litija
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 |
|---|---|---|---|---|---|
| Hungary | 2024-09-11 | 2025-07-25 | 2024-09-11 | 2025-04-13 | |
| Poland | 2024-05-06 | 2025-08-23 | 2024-05-06 | 2025-04-13 | |
| Slovenia | 2024-05-29 | 2025-06-16 | 2024-05-29 | 2025-03-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 28 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | SATELLITE_CRF HQ_clean | 2.0 |
| Protocol (for publication) | SATELLITE_Protocol HQ Final Ver 3 dated 18-APR-2025_redacted | 3.0 |
| Protocol (for publication) | SATELLITE_Protocol HQ_Redacted | 2.0 |
| Protocol (for publication) | SATELLITE_Protocol HU_redacted | 2.0 |
| Protocol (for publication) | SATELLITE_Protocol PL_Redacted | 2.0 |
| Protocol (for publication) | SATELLITE_Protocol SI_redacted | 2.0 |
| Recruitment arrangements (for publication) | HU_RECRUITMENT_ARRANGEMENTS Final Ver 1 dated 5-SEP-2023 | 1 |
| Recruitment arrangements (for publication) | PL_recruitment arrangements Final Ver 1 dated 4-SEP-2023 | 1 |
| Recruitment arrangements (for publication) | SI_RECRUITMENT_ARRANGEMENTS Final Ver. 1.0 dated 30-AUG-2023 | 1.0 |
| Subject information and informed consent form (for publication) | GDPR PL Final Ver 1_1 dated 21-SEP-2023_clean | 1.1 |
| Subject information and informed consent form (for publication) | GDPR SI Final Ver 1 dated 1-SEP-2023 | 1 |
| Subject information and informed consent form (for publication) | GDPR_HU Final Ver 1 dated 30-AUG-2023 | 1 |
| Subject information and informed consent form (for publication) | Patient Diary HU Final Ver 1_1 dated 4-SEP-2023 | 1.1 |
| Subject information and informed consent form (for publication) | Patient Diary PL Final Ver 1_1 dated 6-SEP-2023 | 1.1 |
| Subject information and informed consent form (for publication) | Patient Diary SI Final Ver 1 dated 30-AUG-2023 | 1 |
| Subject information and informed consent form (for publication) | Patient ID Card HU | 1.1 |
| Subject information and informed consent form (for publication) | PI_ICF HU_Redigirano | 2.1 |
| Subject information and informed consent form (for publication) | PI_ICF PL_clean | 2.2 |
| Subject information and informed consent form (for publication) | PI_ICF SI | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | HU_PI_Text040981_1 | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | HU_Tamloset_SMPC_alkalmazasi eloiras | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | PL_PI_Text010804_4 | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | PL_Teldipin_CHPL_SmPC | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SI_PI_Text000837_4 | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | Telmisartan_Amlodipine-SI-SmPC LOCAL-Slovenian-CLEAN-Telassmo | 1 |
| Synopsis of the protocol (for publication) | Protocol summary HU_clean | 3.0 |
| Synopsis of the protocol (for publication) | Protocol summary PL_clean | 3.0 |
| Synopsis of the protocol (for publication) | Protocol summary SI_clean | 3.0 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-22 | Slovenia | Acceptable with conditions 2024-01-15
|
2024-01-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-23 | Slovenia | Acceptable with conditions | 2024-01-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-14 | Acceptable with conditions | 2024-07-22 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-07-23 | Slovenia | 2024-07-23 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-12-20 | Slovenia | 2024-12-20 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-25 | Slovenia | No conclusion 2025-08-03
|
2025-08-18 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-08-22 | No conclusion 2025-08-03
|
2025-08-22 |