Clinical trial • Phase III • Cardiology
Dapagliflozin for Arterial hypertension
Phase III trial of Dapagliflozin for Arterial hypertension.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Arterial hypertension
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 28-07-2025
- First CTIS Authorization Date
- 08-10-2025
Trial design
Randomised, placebo for dapagliflozin (placebo comparator). active investigational product: dapagliflozin ascend 10 mg film-coated tablet (10 mg daily).-controlled Phase III trial in Germany, Slovenia, Spain and others.
- Randomised
- Yes
- Comparator
- Placebo for Dapagliflozin (placebo comparator). Active investigational product: Dapagliflozin Ascend 10 mg film-coated tablet (10 mg daily).
- Target Sample Size
- 3540
- Trial Duration For Participant
- 1460
Eligibility
Recruits 3540 No vulnerable population selected. Exclusion includes: 'Inability to give informed consent'. Subject information and informed consent forms are provided (multiple country/language ICFs are listed); no paediatric/assent procedures are specified..
- Pregnancy Exclusion
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Vulnerable Population
- No vulnerable population selected. Exclusion includes: 'Inability to give informed consent'. Subject information and informed consent forms are provided (multiple country/language ICFs are listed); no paediatric/assent procedures are specified.
Inclusion criteria
- {"criterion_text":"- Age ≥60 years"}
- {"criterion_text":"- Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg in two measurements on different days for newly diagnosed hypertension, or through one measurement at the screening visit for patients with an existing diagnosis of hypertension."}
- {"criterion_text":"- A history of at least one CV event (myocardial infarction* or stroke*; stable angina or clinical evidence of coronary heart disease; peripheral arterial disease; transient ischemic attack) (*excluding patients with myocardial infarction or stroke within preceding 3 months)"}
- {"criterion_text":"- or The presence of at least one cardiovascular risk factor (current smoking of more than one cigarette per day during at least 1 year; LDL-cholesterol ≥ 4,0 mmol/l, Age ≥ 75 years, ESC HeartScore ≥ 15%, BMI ≥ 32 kg/m2, eGFR ≤60 mL/min/1.73m2 (estimated by CKD-EPICr 2021 formula)"}
Exclusion criteria
- {"criterion_text":"- Known secondary cause of hypertension"}
- {"criterion_text":"- Myocardial infarction or stroke within the previous 3 months"}
- {"criterion_text":"- Symptomatic heart failure (including HFrEF, HFmEF, HFpEF)"}
- {"criterion_text":"- History of Diabetes mellitus"}
- {"criterion_text":"- History of ketoacidosis"}
- {"criterion_text":"- Hepatic impairment (aspartate transaminase [AST] or alanine transaminase [ALT] ≥3x the upper limit of normal [ULN])"}
- {"criterion_text":"- eGFR ≤25 mL/min/1.73 m2 (CKD-EPICr 2021 formula) at Visit 1"}
- {"criterion_text":"- Receiving therapy with an SGLT2i within 8 weeks prior to randomization or previous intolerance to an SGLT2i"}
- {"criterion_text":"- Participation in another clinical study with an investigational product during the last month prior to enrolment"}
- {"criterion_text":"- Known allergy or hypersensitivity to SGLT2i"}
- {"criterion_text":"- Women who are pregnant, nursing, or who plan to become pregnant while in the trial"}
- {"criterion_text":"- Any medical condition - outside the renal and CV disease area - with a life expectancy of less than 2 years based on investigator’s clinical judgement"}
- {"criterion_text":"- Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma)"}
- {"criterion_text":"- Inability to give informed consent"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Time until first occurrence of","definition_or_measurement_approach":"Time-to-event composite endpoint: time from randomisation to first occurrence of any of the listed events."}
- {"endpoint_text":"-\tnon-fatal stroke,","definition_or_measurement_approach":"Component of composite: occurrence of non-fatal stroke as adjudicated per study procedures."}
- {"endpoint_text":"-\tnon-fatal myocardial infarction,","definition_or_measurement_approach":"Component of composite: occurrence of non-fatal myocardial infarction as adjudicated per study procedures."}
- {"endpoint_text":"-\trevascularisation procedures for atherosclerotic disease,","definition_or_measurement_approach":"Component of composite: documented coronary or peripheral revascularisation procedures."}
- {"endpoint_text":"-\thospitalisation or emergency department for HF,","definition_or_measurement_approach":"Component of composite: hospitalisation or ED visit for heart failure according to protocol definitions."}
- {"endpoint_text":"-\tunplanned hospitalisation for new-onset atrial fibrillation (AF), new-onset atrial flutter (AFL) or ventricular arrhythmia,","definition_or_measurement_approach":"Component of composite: unplanned hospitalisation for new-onset AF/AFL or ventricular arrhythmia."}
- {"endpoint_text":"-\tsustained decline in the eGFR of at least 50% (estimated by CKD-EPICr 2021 formula)","definition_or_measurement_approach":"Renal component defined as sustained ≥50% decline in eGFR estimated by CKD-EPICr 2021 formula."}
- {"endpoint_text":"-\tend-stage kidney disease o\tdefined as eGFR <15 mL/min/1.73m2 or requiring chronic dialysis or renal transplantation,","definition_or_measurement_approach":"End-stage kidney disease defined as eGFR <15 mL/min/1.73m2 or initiation of chronic dialysis or renal transplantation."}
- {"endpoint_text":"-\tdeath from renal or CV causes","definition_or_measurement_approach":"Component of composite: death adjudicated as due to renal or cardiovascular causes."}
Secondary endpoints
- {"endpoint_text":"- Individual components of the primary composite outcome","definition_or_measurement_approach":"Each component of the primary composite analysed separately."}
- {"endpoint_text":"- All-cause mortality","definition_or_measurement_approach":"Death from any cause."}
- {"endpoint_text":"- Rate of the decline in the eGFR, estimated by CKD-EPICr 2021 formula at 8 weeks and 48 months","definition_or_measurement_approach":"Change in eGFR over time estimated by CKD-EPICr 2021 formula with assessments at 8 weeks and 48 months."}
- {"endpoint_text":"- Change in systolic BP at 8 weeks, 12 months and 48 months","definition_or_measurement_approach":"Change from baseline in systolic blood pressure at specified time points."}
- {"endpoint_text":"- Change in diastolic BP at 8 weeks, 12 months and 48 months","definition_or_measurement_approach":"Change from baseline in diastolic blood pressure at specified time points."}
- {"endpoint_text":"- Composite of primary endpoint or death from any cause","definition_or_measurement_approach":"Composite endpoint combining primary composite or all-cause death."}
- {"endpoint_text":"- Development of type 2 diabetes,","definition_or_measurement_approach":"New onset type 2 diabetes as defined by study criteria."}
- {"endpoint_text":"- Time to coronary revascularization procedure","definition_or_measurement_approach":"Time from randomisation to first coronary revascularisation procedure."}
- {"endpoint_text":"- Improvement in quality of life (respective area-under-the-curve (AUC) of EQ VAS Score and HeartQoL Global Score changes. (Assessment Points: Baseline, 12 months, 24, and 48 months).","definition_or_measurement_approach":"QoL measured by EQ VAS and HeartQoL Global Score; AUC over assessment points baseline, 12, 24, 48 months."}
- {"endpoint_text":"- Decline of cognition (MoCA Test Score, Assessment Points: Baseline, 12 months, 24, and 48 months)","definition_or_measurement_approach":"Cognitive decline measured by MoCA score at specified assessment points."}
- {"endpoint_text":"- Increase of blood markers of neurodegeneration (Ptau 217, Nfl) (Assessment Points: Baseline, 12 months, 24, and 48 months)","definition_or_measurement_approach":"Biomarker changes (Ptau217, NfL) measured in blood at specified time points."}
- {"endpoint_text":"- Frailty (Assessment Points: Baseline, 12 months, 24, and 48 months)","definition_or_measurement_approach":"Frailty assessments at specified time points (protocol-defined instruments)."}
Recruitment
- Planned Sample Size
- 3540
- Recruitment Window Months
- 96
- Consent Approach
- Informed consent required; 'Inability to give informed consent' is an exclusion. Subject information and informed consent forms are provided for multiple countries; published ICF documents include English, Spanish, German, Italian and Slovenian versions. No paediatric assent procedures are specified.
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 3540
Germany
- Earliest CTIS Part Ii Submission Date
- 23-09-2025
- Latest Decision Or Authorization Date
- 08-10-2025
- Processing Time Days
- 15
- Number Of Sites
- 16
- Number Of Participants
- 3112
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik für Kardiologie, Angiologie und Intensivmedizin Campus Virchow-Klinikum
- Principal Investigator Name
- Kun Zhang
- Principal Investigator Email
- kun.zhang@dhzc-charite.de
- Contact Person Name
- Kun Zhang
- Contact Person Email
- kun.zhang@dhzc-charite.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Medical Clinica II
- Principal Investigator Name
- Ingo Eitel
- Principal Investigator Email
- ingo.eitel@uksh.de
- Contact Person Name
- Ingo Eitel
- Contact Person Email
- ingo.eitel@uksh.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Internal Medicine II
- Principal Investigator Name
- Wolfgang Rottbauer
- Principal Investigator Email
- wolfgang.rottbauer@uniklinik-ulm.de
- Contact Person Name
- Wolfgang Rottbauer
- Contact Person Email
- wolfgang.rottbauer@uniklinik-ulm.de
- Site Name
- Stiftung Bremer Herzen
- Department Name
- Cardiology
- Principal Investigator Name
- Harm Wienbergen
- Principal Investigator Email
- harm.wienbergen@gesundheitnord.de
- Contact Person Name
- Harm Wienbergen
- Contact Person Email
- harm.wienbergen@gesundheitnord.de
- Site Name
- Universitaetsklinikum Koeln AöR
- Department Name
- Universitäre Herzzentrum in Köln
- Principal Investigator Name
- Marcel Halbach
- Principal Investigator Email
- marcel.halbach@uk-koeln.de
- Contact Person Name
- Marcel Halbach
- Contact Person Email
- marcel.halbach@uk-koeln.de
- Site Name
- Universitaetsklinikum Mannheim GmbH
- Department Name
- Universitäre Herzzentrum Mannheim
- Principal Investigator Name
- Ibrahim Akin
- Principal Investigator Email
- Ibrahim.Akin@umm.de
- Contact Person Name
- Ibrahim Akin
- Contact Person Email
- Ibrahim.Akin@umm.de
- Site Name
- Otto Von Guericke Universitaet Magdeburg
- Department Name
- Zentrum für Innere Medizin Universitätsklinik für Kardiologie und Angiologie
- Principal Investigator Name
- Rüdiger Christian Braun-Dullaeus
- Principal Investigator Email
- r.braun-dullaeus@med.ovgu.de
- Contact Person Name
- Rüdiger Christian Braun-Dullaeus
- Contact Person Email
- r.braun-dullaeus@med.ovgu.de
- Site Name
- SANA Kliniken Oberfranken Coburg GmbH
- Department Name
- II Medical Clinic - Clinic for cardiology and angiology
- Principal Investigator Name
- Steffen Schnupp
- Principal Investigator Email
- steffen.schnupp@regiomed-kliniken.de
- Contact Person Name
- Steffen Schnupp
- Contact Person Email
- steffen.schnupp@regiomed-kliniken.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Deutsches Herzzentrum der Charité
- Principal Investigator Name
- Ulf Landmesser
- Principal Investigator Email
- ulf.landmesser@dhzc-charite.de
- Contact Person Name
- Ulf Landmesser
- Contact Person Email
- ulf.landmesser@dhzc-charite.de
- Site Name
- Rostock University Medical Center
- Department Name
- Klinik und Poliklinik für Kardiologie, Department für Innere Medizin
- Principal Investigator Name
- Hüseyin Ince
- Principal Investigator Email
- Hueseyin.Ince@med.uni-rostock.de
- Contact Person Name
- Hüseyin Ince
- Contact Person Email
- Hueseyin.Ince@med.uni-rostock.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Kardiologie und Angiologie
- Principal Investigator Name
- Tienush Rassaf
- Principal Investigator Email
- tienush.rassaf@uk-essen.de
- Contact Person Name
- Tienush Rassaf
- Contact Person Email
- tienush.rassaf@uk-essen.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie und internistische Intensivmedizin
- Principal Investigator Name
- Derk Frank
- Principal Investigator Email
- Derk.Frank@uksh.de
- Contact Person Name
- Derk Frank
- Contact Person Email
- Derk.Frank@uksh.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Devision of cardiology, Pulmonology and Vascular Medicine
- Principal Investigator Name
- Lucas Busch
- Principal Investigator Email
- hanslucas.busch@med.uni-duesseldorf.de
- Contact Person Name
- Lucas Busch
- Contact Person Email
- hanslucas.busch@med.uni-duesseldorf.de
- Site Name
- Segeberger Kliniken GmbH
- Department Name
- Kardiologie im Herz- und Gefäßzentrum
- Principal Investigator Name
- Stephan Fichtlscherer
- Principal Investigator Email
- Stephan.Fichtlscherer@segebergerkliniken.de
- Contact Person Name
- Stephan Fichtlscherer
- Contact Person Email
- Stephan.Fichtlscherer@segebergerkliniken.de
- Site Name
- Johannes Gutenberg University Mainz
- Department Name
- Zentrum für Kardiologie
- Principal Investigator Name
- Karl Philipp Rommel
- Principal Investigator Email
- Karl_Ph.Rommel@unimedizin-mainz.de
- Contact Person Name
- Karl Philipp Rommel
- Contact Person Email
- Karl_Ph.Rommel@unimedizin-mainz.de
- Site Name
- Universitaet Leipzig
- Department Name
- Klinik und Poliklinik für Kardiologie
- Principal Investigator Name
- Rolf Wachter
- Principal Investigator Email
- Rolf.Wachter@medizin.uni-leipzig.de
- Contact Person Name
- Rolf Wachter
- Contact Person Email
- Rolf.Wachter@medizin.uni-leipzig.de
Slovenia
- Earliest CTIS Part Ii Submission Date
- 05-02-2026
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 54
- Number Of Sites
- 1
- Number Of Participants
- 50
Sites
- Site Name
- University Medical Center Ljubljana
- Department Name
- University Medical Centre, Department of Hypertension
- Principal Investigator Name
- Jana Brguljan Hitij
- Principal Investigator Email
- jana.brguljan@kclj.si
- Contact Person Name
- Jana Brguljan Hitij
- Contact Person Email
- jana.brguljan@kclj.si
Spain
- Earliest CTIS Part Ii Submission Date
- 19-03-2026
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 12
- Number Of Sites
- 1
- Number Of Participants
- 100
Sites
- Site Name
- Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
- Department Name
- Instituto de Investigación Sanitaria - Hospital Universitario Fundación Jiménez Díaz
- Principal Investigator Name
- Borja Ibáñez Cabeza
- Principal Investigator Email
- bibanez@cnic.es
- Contact Person Name
- Borja Ibáñez Cabeza
- Contact Person Email
- bibanez@cnic.es
Austria
- Earliest CTIS Part Ii Submission Date
- 31-03-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 34
- Number Of Sites
- 1
- Number Of Participants
- 100
Sites
- Site Name
- Universitätsklinik für Neuroradiologie, Medizinische Universität Innsbruck
- Department Name
- Univ.-Klinik für Innere Medizin III
- Principal Investigator Name
- Sebastian Reinstadler
- Principal Investigator Email
- sebastian.reinstadler@i-med.ac.at
- Contact Person Name
- Sebastian Reinstadler
- Contact Person Email
- sebastian.reinstadler@i-med.ac.at
Portugal
- Earliest CTIS Part Ii Submission Date
- 16-02-2026
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 57
- Number Of Sites
- 1
- Number Of Participants
- 55
Sites
- Site Name
- University Of Porto
- Department Name
- Departamento Cirurgia e Fisiologia
- Principal Investigator Name
- João Pedro Ferreira
- Principal Investigator Email
- jpferreira@med.up.pt
- Contact Person Name
- João Pedro Ferreira
- Contact Person Email
- jpferreira@med.up.pt
Italy
- Earliest CTIS Part Ii Submission Date
- 22-04-2026
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 8
- Number Of Sites
- 2
- Number Of Participants
- 123
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Azienda Ospedaliero-Universitaria di Bologna (AOUBO)
- Principal Investigator Name
- Luciano Potena
- Principal Investigator Email
- luciano.potena2@unibo.it
- Contact Person Name
- Luciano Potena
- Contact Person Email
- luciano.potena2@unibo.it
- Site Name
- Azienda Ospedaliero Universitaria - Policlinico Riuniti Foggia
- Department Name
- S.C Cardiologia Universitaria
- Principal Investigator Name
- Francesco Santoro
- Principal Investigator Email
- dr.francesco.santoro.it@gmail.com
- Contact Person Name
- Francesco Santoro
- Contact Person Email
- dr.francesco.santoro.it@gmail.com
Sponsor
Primary sponsor
- Full Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Third parties
- {"country":"France","full_name":"Institut National De La Sante Et De La Recherche Medicale","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"Ascend GmbH","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Fondation Force Pour L'Innovation Et La Recherche En Sante","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"EvidentlQ Germany GmbH","duties_or_roles":"sponsorDuties codes: [3,7,8]","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Dapagliflozin Ascend 10 mg Filmtabletten
- Active Substance
- Dapagliflozin
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (marketing authorisation number 7001787.00.00 in DE)
- Starting Dose
- 10 mg
- Dose Levels
- 10 mg (single dose level specified)
- Frequency
- Once daily
- Maximum Dose
- 10 mg
- Investigational Product Name
- Placebo for Dapagliflozin
- Modality
- Other
- Authorisation Status
- Not applicable / placebo
- Combination Treatment
- Yes
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