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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06424288




Registration number
NCT06424288
Ethics application status
Date submitted
10/05/2024
Date registered
22/05/2024

Titles & IDs
Public title
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
Scientific title
EASi-HF Preserved - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) =40%
Secondary ID [1] 0 0
2023-509706-30-00
Secondary ID [2] 0 0
1378-0020
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - vicadrostat
Treatment: Drugs - Empagliflozin
Treatment: Drugs - Placebo

Experimental: vicadrostat + empagliflozin -

Placebo comparator: Placebo + empagliflozin -


Treatment: Drugs: vicadrostat
Vicadrostat

Treatment: Drugs: Empagliflozin
Empagliflozin

Treatment: Drugs: Placebo
Placebo matching BI 690517
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first event of Cardiovascular (CV) death, hospitalisation for heart failure (HHF) or urgent heart failure (HF) visit
Timepoint [1] 0 0
up to 42 months
Secondary outcome [1] 0 0
Key secondary endpoint: Time to first event of CV death or HHF
Timepoint [1] 0 0
up to 42 months
Secondary outcome [2] 0 0
Key secondary endpoint: Occurrence of HHFs (first and recurrent)
Timepoint [2] 0 0
up to 42 months
Secondary outcome [3] 0 0
Key secondary endpoint: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) at Week 32
Timepoint [3] 0 0
at baseline, at week 32
Secondary outcome [4] 0 0
Key secondary endpoint: Time to CV death
Timepoint [4] 0 0
up to 42 months
Secondary outcome [5] 0 0
Key secondary endpoint: Time to all-cause mortality
Timepoint [5] 0 0
up to 42 months
Secondary outcome [6] 0 0
Time to first HHF
Timepoint [6] 0 0
up to 42 months
Secondary outcome [7] 0 0
Time to first occurrence of death from kidney failure, chronic dialysis* or renal transplant or onset of sustained reduction of =50% eGFR from baseline** or onset of sustained eGFR (CKD-EPI)cr <10 mL/min/1.73 m2 (composite renal endpoint)
Timepoint [7] 0 0
up to 42 months
Secondary outcome [8] 0 0
Absolute change from baseline in KCCQ Clinical Summary Score (KCCQ-CSS) at Week 32
Timepoint [8] 0 0
at baseline, at week 32
Secondary outcome [9] 0 0
Absolute change from baseline in KCCQ-TSS at Week 52
Timepoint [9] 0 0
at baseline, at week 52
Secondary outcome [10] 0 0
Absolute change from baseline in KCCQ-OSS at Week 32
Timepoint [10] 0 0
at baseline, at week 32
Secondary outcome [11] 0 0
Absolute change from baseline in KCCQ-OSS at Week 52
Timepoint [11] 0 0
at baseline, at week 52
Secondary outcome [12] 0 0
Absolute change from baseline in systolic blood pressure (SBP) [mmHg] at Week 32 in participants with baseline SBP =130 mmHg
Timepoint [12] 0 0
at baseline, at week 32
Secondary outcome [13] 0 0
Absolute chance from baseline in diastolic blood pressure (DBP) [mmHg] at Week 32 in participants with baseline DBP =80 mmHg
Timepoint [13] 0 0
at baseline, at week 32

Eligibility
Key inclusion criteria
Inclusion criteria:

1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information
4. Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) =40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2
5. Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2
6. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:

1. in participants with body mass index (BMI) <27 kg/m²: =300 pg/mL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and =900 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
2. in participants with BMI =27 kg/m² to <35 kg/m²: =220 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and =660 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
3. in participants with BMI =35 kg/m²: =125 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and =375 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
7. At least one of the following:

* Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1
* Documented hospitalisation for HF within 6 months prior to Visit 1
* Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1

* in participants without Afib or Aflutter (at Visit 1 ECG): =900 pg/mL
* for participants with Afib or Aflutter (at Visit 1 ECG): =1800 pg/mL
* Urine albumin-to-creatinine ratio (UACR) =30 mg/g, analysed at the central laboratory at Visit 1
8. Treated according to best possible standard of care (SOC) (disregarding Sodium-dependent glucose co-transporter 2 inhibitors (SGLT2is) and Mineralocorticoid receptor antagonists (MRAs)) in accordance with applicable HF local/international guidelines and judgment of the investigator Further inclusion criteria apply.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Treatment with an mineralocorticoid receptor antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with MRA should not be interrupted with the intention of enrolment into the study
2. Treatment with amiloride, or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator
3. Receiving the following treatments:

* a direct renin inhibitor (e.g. aliskiren) at Visit 2
* more than one angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) used simultaneously at Visit 2
* In case of acute decompensated HF:

* i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation (Visit 2)
* i.v. diuretic with a dose that has been increased/intensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)
* Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2
* Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery/intervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, coronary artery bypass graft surgery/CABG)
5. Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2
6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)
7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or genetic hypertrophic cardiomyopathy,known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit 2
8. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2
9. Known severe valvular heart disease (obstructive or regurgitant), as per investigator's judgment, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment during the study Further exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/11/2027
Actual
Sample size
Target
6000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Gosford Hospital - Gosford
Recruitment hospital [4] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [5] 0 0
Pendlebury Research - Kotara
Recruitment hospital [6] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [7] 0 0
John Flynn Private Hospital - Tugun
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [10] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [11] 0 0
Mount Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2747 - Kingswood
Recruitment postcode(s) [5] 0 0
2289 - Kotara
Recruitment postcode(s) [6] 0 0
4029 - Brisbane
Recruitment postcode(s) [7] 0 0
4224 - Tugun
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
5011 - Woodville
Recruitment postcode(s) [10] 0 0
3050 - Parkville
Recruitment postcode(s) [11] 0 0
6000 - Perth
Recruitment outside Australia
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Alabama
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California
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Idaho
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Illinois
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Prag
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Smirice
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Baja
Country [156] 0 0
Hungary
State/province [156] 0 0
Budapest
Country [157] 0 0
Hungary
State/province [157] 0 0
Gyula
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Hungary
State/province [158] 0 0
Hatvan
Country [159] 0 0
Hungary
State/province [159] 0 0
Miskolc
Country [160] 0 0
Hungary
State/province [160] 0 0
Oroshaza
Country [161] 0 0
Hungary
State/province [161] 0 0
Pecs
Country [162] 0 0
Hungary
State/province [162] 0 0
Szeged
Country [163] 0 0
Hungary
State/province [163] 0 0
Szekszard
Country [164] 0 0
Hungary
State/province [164] 0 0
Szolnok
Country [165] 0 0
Hungary
State/province [165] 0 0
Zalaegerszeg
Country [166] 0 0
India
State/province [166] 0 0
Aurangabad
Country [167] 0 0
India
State/province [167] 0 0
Bengaluru
Country [168] 0 0
India
State/province [168] 0 0
Bikaner
Country [169] 0 0
India
State/province [169] 0 0
Chennai
Country [170] 0 0
India
State/province [170] 0 0
Gurgaon
Country [171] 0 0
India
State/province [171] 0 0
Guwahati
Country [172] 0 0
India
State/province [172] 0 0
Kolkata
Country [173] 0 0
India
State/province [173] 0 0
Vishakhapatnam
Country [174] 0 0
Italy
State/province [174] 0 0
Bergamo
Country [175] 0 0
Italy
State/province [175] 0 0
Foggia
Country [176] 0 0
Italy
State/province [176] 0 0
Genova
Country [177] 0 0
Italy
State/province [177] 0 0
Pavia
Country [178] 0 0
Italy
State/province [178] 0 0
Roma
Country [179] 0 0
Japan
State/province [179] 0 0
Fukuoka, Kitakyushu
Country [180] 0 0
Japan
State/province [180] 0 0
Himeji-shi
Country [181] 0 0
Japan
State/province [181] 0 0
Hokkaido, Sapporo
Country [182] 0 0
Japan
State/province [182] 0 0
Hokkaido, Tomakomai
Country [183] 0 0
Japan
State/province [183] 0 0
Hyogo, Amagasaki
Country [184] 0 0
Japan
State/province [184] 0 0
Iwakuni-shi
Country [185] 0 0
Japan
State/province [185] 0 0
Kagawa, Takamatsu
Country [186] 0 0
Japan
State/province [186] 0 0
Kanagawa, Yokohama
Country [187] 0 0
Japan
State/province [187] 0 0
Kanonji-shi
Country [188] 0 0
Japan
State/province [188] 0 0
Kishiwada-shi
Country [189] 0 0
Japan
State/province [189] 0 0
Kitaazumi-gun
Country [190] 0 0
Japan
State/province [190] 0 0
Matsuyama-shi
Country [191] 0 0
Japan
State/province [191] 0 0
Miura-gun
Country [192] 0 0
Japan
State/province [192] 0 0
Nagano, Matsumoto
Country [193] 0 0
Japan
State/province [193] 0 0
Nakano-shi
Country [194] 0 0
Japan
State/province [194] 0 0
Oita, Oita
Country [195] 0 0
Japan
State/province [195] 0 0
Okinawa, Naha
Country [196] 0 0
Japan
State/province [196] 0 0
Okinawa, Urasoe
Country [197] 0 0
Japan
State/province [197] 0 0
Osaka, Osaka
Country [198] 0 0
Japan
State/province [198] 0 0
Saga-shi
Country [199] 0 0
Japan
State/province [199] 0 0
Saitama-shi
Country [200] 0 0
Japan
State/province [200] 0 0
Suita-shi
Country [201] 0 0
Japan
State/province [201] 0 0
Tokyo, Ome
Country [202] 0 0
Japan
State/province [202] 0 0
Tomakomai-shi
Country [203] 0 0
Korea, Republic of
State/province [203] 0 0
Seoul
Country [204] 0 0
Korea, Republic of
State/province [204] 0 0
Wonju-si, Gangwon State
Country [205] 0 0
Mexico
State/province [205] 0 0
Aguascalientes
Country [206] 0 0
Mexico
State/province [206] 0 0
Culiacan
Country [207] 0 0
Mexico
State/province [207] 0 0
Distrito Federal
Country [208] 0 0
Mexico
State/province [208] 0 0
Guadalajara
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Mexico
State/province [209] 0 0
Irapuato
Country [210] 0 0
Mexico
State/province [210] 0 0
Mazatlan
Country [211] 0 0
Mexico
State/province [211] 0 0
Monterrey
Country [212] 0 0
Mexico
State/province [212] 0 0
Tlalnepantla
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Mexico
State/province [213] 0 0
Torreon
Country [214] 0 0
Netherlands
State/province [214] 0 0
Breda
Country [215] 0 0
Netherlands
State/province [215] 0 0
Deventer
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Netherlands
State/province [216] 0 0
Leiderdorp
Country [217] 0 0
Netherlands
State/province [217] 0 0
Nieuwegein
Country [218] 0 0
Netherlands
State/province [218] 0 0
Rotterdam
Country [219] 0 0
Netherlands
State/province [219] 0 0
s Hertogenbosch
Country [220] 0 0
Poland
State/province [220] 0 0
Bialystok
Country [221] 0 0
Poland
State/province [221] 0 0
Bydgoszcz
Country [222] 0 0
Poland
State/province [222] 0 0
Gdansk
Country [223] 0 0
Poland
State/province [223] 0 0
Gdynia
Country [224] 0 0
Poland
State/province [224] 0 0
Katowice
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Poland
State/province [225] 0 0
Kielce
Country [226] 0 0
Poland
State/province [226] 0 0
Krakow
Country [227] 0 0
Poland
State/province [227] 0 0
Kraków
Country [228] 0 0
Poland
State/province [228] 0 0
Legnica
Country [229] 0 0
Poland
State/province [229] 0 0
Lodz
Country [230] 0 0
Poland
State/province [230] 0 0
Lublin
Country [231] 0 0
Poland
State/province [231] 0 0
Olsztyn
Country [232] 0 0
Poland
State/province [232] 0 0
Oswiecim
Country [233] 0 0
Poland
State/province [233] 0 0
Piaseczno
Country [234] 0 0
Poland
State/province [234] 0 0
Rzeszow
Country [235] 0 0
Poland
State/province [235] 0 0
Siedlce
Country [236] 0 0
Poland
State/province [236] 0 0
Skierniewice
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Poland
State/province [237] 0 0
Sochaczew
Country [238] 0 0
Poland
State/province [238] 0 0
Sopot
Country [239] 0 0
Poland
State/province [239] 0 0
Staszow
Country [240] 0 0
Poland
State/province [240] 0 0
Warsaw
Country [241] 0 0
Poland
State/province [241] 0 0
Warszawa
Country [242] 0 0
Poland
State/province [242] 0 0
Wroclaw
Country [243] 0 0
Poland
State/province [243] 0 0
Zamosc
Country [244] 0 0
Poland
State/province [244] 0 0
Zarow
Country [245] 0 0
Romania
State/province [245] 0 0
Braila
Country [246] 0 0
Romania
State/province [246] 0 0
Bucharest
Country [247] 0 0
Romania
State/province [247] 0 0
Bucuresti
Country [248] 0 0
Romania
State/province [248] 0 0
Iasi
Country [249] 0 0
Romania
State/province [249] 0 0
Pitesti
Country [250] 0 0
Romania
State/province [250] 0 0
Targu Mures
Country [251] 0 0
Romania
State/province [251] 0 0
Timisoara
Country [252] 0 0
Saudi Arabia
State/province [252] 0 0
Jeddah
Country [253] 0 0
Saudi Arabia
State/province [253] 0 0
Riyadh
Country [254] 0 0
Serbia
State/province [254] 0 0
Belgrade
Country [255] 0 0
Serbia
State/province [255] 0 0
Kragujevac
Country [256] 0 0
Serbia
State/province [256] 0 0
Nis
Country [257] 0 0
Serbia
State/province [257] 0 0
Pancevo
Country [258] 0 0
Serbia
State/province [258] 0 0
Smederevo
Country [259] 0 0
Serbia
State/province [259] 0 0
Zajecar
Country [260] 0 0
Slovenia
State/province [260] 0 0
Celje
Country [261] 0 0
Slovenia
State/province [261] 0 0
Golnik
Country [262] 0 0
Slovenia
State/province [262] 0 0
Jesenice
Country [263] 0 0
Slovenia
State/province [263] 0 0
Ljubljana
Country [264] 0 0
Slovenia
State/province [264] 0 0
Murska Sobota
Country [265] 0 0
Slovenia
State/province [265] 0 0
Trbovlje
Country [266] 0 0
South Africa
State/province [266] 0 0
Bloemfontein
Country [267] 0 0
South Africa
State/province [267] 0 0
Cape Town
Country [268] 0 0
South Africa
State/province [268] 0 0
Centurion
Country [269] 0 0
South Africa
State/province [269] 0 0
Johannesburg
Country [270] 0 0
South Africa
State/province [270] 0 0
Somerset West
Country [271] 0 0
South Africa
State/province [271] 0 0
Worcester
Country [272] 0 0
Spain
State/province [272] 0 0
Barcelona
Country [273] 0 0
Spain
State/province [273] 0 0
El Palmar
Country [274] 0 0
Spain
State/province [274] 0 0
Madrid
Country [275] 0 0
Spain
State/province [275] 0 0
Sanlúcar de Barrameda
Country [276] 0 0
Spain
State/province [276] 0 0
Santiago de Compostela
Country [277] 0 0
Spain
State/province [277] 0 0
Valencia
Country [278] 0 0
Spain
State/province [278] 0 0
Villamartin, Cardiz
Country [279] 0 0
Taiwan
State/province [279] 0 0
Kaohsiung
Country [280] 0 0
Taiwan
State/province [280] 0 0
Taichung
Country [281] 0 0
Taiwan
State/province [281] 0 0
Taipei City
Country [282] 0 0
Taiwan
State/province [282] 0 0
Taipei
Country [283] 0 0
Taiwan
State/province [283] 0 0
Taoyuan County
Country [284] 0 0
Turkey
State/province [284] 0 0
Adana
Country [285] 0 0
Turkey
State/province [285] 0 0
Ankara
Country [286] 0 0
Turkey
State/province [286] 0 0
Elazig
Country [287] 0 0
Turkey
State/province [287] 0 0
Erzurum
Country [288] 0 0
Turkey
State/province [288] 0 0
Eskisehir
Country [289] 0 0
Turkey
State/province [289] 0 0
Gaziantep
Country [290] 0 0
Turkey
State/province [290] 0 0
Istanbul
Country [291] 0 0
Turkey
State/province [291] 0 0
Izmir
Country [292] 0 0
Turkey
State/province [292] 0 0
Kutahya
Country [293] 0 0
Turkey
State/province [293] 0 0
Malatya
Country [294] 0 0
Turkey
State/province [294] 0 0
Mersin
Country [295] 0 0
Turkey
State/province [295] 0 0
Pendik/ Istanbul
Country [296] 0 0
Turkey
State/province [296] 0 0
Trabzon
Country [297] 0 0
United Kingdom
State/province [297] 0 0
Barnet
Country [298] 0 0
United Kingdom
State/province [298] 0 0
Halifax
Country [299] 0 0
United Kingdom
State/province [299] 0 0
London
Country [300] 0 0
United Kingdom
State/province [300] 0 0
Sheffield
Country [301] 0 0
Vietnam
State/province [301] 0 0
Hanoi
Country [302] 0 0
Vietnam
State/province [302] 0 0
Ho Chi Minh City
Country [303] 0 0
Vietnam
State/province [303] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06424288