Comparison of Myval THV Series With Guideline-Directed Medical Therapy in Participants With Moderate Aortic Stenosis

April 29, 2026 updated by: Meril Life Sciences Pvt. Ltd.

A Prospective, Multinational, Multicentre, Open-label, Randomized Trial to Evaluate Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series Compared to Guideline-Directed Medical Therapy (GDMT) in Participants With Moderate Aortic Stenosis.

The primary objective of this trial is to evaluate the safety and effectiveness of Meril's Myval THV series in comparison to Guideline-Directed Medical Therapy in participants with moderate aortic stenosis. The trial includes a total of 778 participants (389:389) from approximately 50 investigator sites globally.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants with symptomatic moderate aortic stenosis OR asymptomatic moderate aortic stenosis with evidence of cardiac damage as assessed by echocardiography core lab.

Study Type

Interventional

Enrollment (Estimated)

778

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia
    • Queensland
      • Brisbane, Queensland, Australia
    • Victoria
      • Melbourne, Victoria, Australia
  • Belarus
    • Minsk Oblast
      • Minsk, Minsk Oblast, Belarus, 220036
        • Republican Scientific and Practical Center of Cardiology (RSPC Cardiology)
        • Contact:
  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 04012-909
        • Instituto Dante Pazzanese de Cardiologia
        • Contact:
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
    • Capital Region of Denmark (Hovedstaden)
      • Copenhagen, Capital Region of Denmark (Hovedstaden), Denmark, 2100
        • Rigshospitalet, Copenhagen University Hospital
        • Contact:
  • Estonia
    • Harju
      • Tallinn, Harju, Estonia, 13419
  • Finland
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20521
      • Turku, Southwest Finland, Finland, 20521
        • Turku University Hospital (Tyks), Heart Centre
        • Contact:
  • France
    • Auvergne-Rhône-Alpes
      • Villeurbanne, Auvergne-Rhône-Alpes, France, 69100
        • Medipole Lyon-Villeurbanne
        • Contact:
    • Brittany Region
      • Rennes, Brittany Region, France, 35033
    • Centre-Val de Loire
      • Tours, Centre-Val de Loire, France, 37044
        • Centre Hospitalier Universitaire de Tours
        • Contact:
    • Essonne
      • Massy, Essonne, France, 91300
        • Hôpital Privé Jacques Cartier (ICPS - Institut Cardiovasculaire Paris Sud)
        • Contact:
    • Grand Est
      • Strasbourg, Grand Est, France, 67091
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31300
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59037
        • Centre Hospitalier Regional Universitaire de Lille
        • Contact:
    • New Aquitaine
      • Bordeaux, New Aquitaine, France
    • Occitanie
      • Toulouse, Occitanie, France, 31059
        • Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
        • Contact:
    • Provence-Alpes-Côte d'Azur Region
      • Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
        • Hôpital de la Timone - Assistance Publique Hôpitaux de Marseille
        • Contact:
      • Saint-Laurent-du-Var, Provence-Alpes-Côte d'Azur Region, France, 06700
    • Île-de-France Region
      • Créteil, Île-de-France Region, France, 94010
        • Hôpital Henri-Mondor - Assistance Publique Hôpitaux de Paris
        • Contact:
      • Saint-Denis, Île-de-France Region, France, 93200
  • Germany
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
    • Bavaria
    • Hesse
      • Bad Nauheim, Hesse, Germany, 61231
    • Lower Saxony
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Herzzentrum Dresden GmbH Universitätsklinik
        • Contact:
      • Leipzig, Saxony, Germany, 04103
  • Italy
    • Milan
      • Milan, Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele
        • Contact:
      • Milan, Milan, Italy, 20157
        • IRCCS Ospedale Galeazzi - Sant'Ambrogio
        • Contact:
      • San Donato Milanese, Milan, Italy, 20097
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
    • North Brabant
      • Breda, North Brabant, Netherlands, 4818 CK
      • Eindhoven, North Brabant, Netherlands, 5623 EJ
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1091 AC
        • OLVG
        • Contact:
          • Giovanni Amoroso, MD
          • Phone Number: +31 20 599 91 11
        • Contact:
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Erasmus Medical Center
        • Contact:
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3435 CM
      • Utrecht, Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
        • Contact:
  • New Zealand
    • Auckland
      • Auckland, Auckland, New Zealand, 1023
        • Auckland City Hospital
        • Contact:
    • Waikato Region
  • North Macedonia
    • Grad Skopje
      • Skopje, Grad Skopje, North Macedonia, 1000
        • University Clinic of Cardiology Skopje
        • Contact:
  • Norway
    • Oslo
      • Oslo, Oslo, Norway, 0372
  • Slovakia
    • Banská Bystrica Region
      • Banská Bystrica, Banská Bystrica Region, Slovakia, 974 01
        • Middle Slovak Institute of Cardiovascular Diseases (SÚSCCH)
        • Contact:
  • Slovenia
    • Osrednjeslovenska
      • Ljubljana, Osrednjeslovenska, Slovenia, 1000
        • University Medical Centre Ljubljana
        • Contact:
  • South Africa
    • Gauteng
      • Sandton, Gauteng, South Africa, 2191
  • Spain
    • Andalusia
      • Seville, Andalusia, Spain, 41013
        • Hospital Universitario Virgen del Rocío
        • Contact:
    • Aragon
      • Zaragoza, Aragon, Spain, 50009
        • Hospital Universitario Miguel Servet
        • Contact:
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07120
        • Hospital Universitario Son Espases
        • Contact:
    • Castille and León
      • Salamanca, Castille and León, Spain, 37007
        • Hospital Clinico Universitario de Salamanca
        • Contact:
      • Valladolid, Castille and León, Spain, 47003
        • Hospital Clinico Universitario de Valladolid
        • Contact:
          • Ignacio J. Amat-Santos, MD, PhD
          • Phone Number: +34 983 42 00 00
          • Email: ijamat@gmail.com
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • Hospital Clínic de Barcelona
        • Contact:
    • Córdoba
      • Córdoba, Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
        • Contact:
    • Galicia
      • Vigo, Galicia, Spain, 36213
        • Hospital Álvaro Cunqueiro
        • Contact:
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrin
        • Contact:
    • Madrid
      • Madrid, Madrid, Spain, 28046
      • Madrid, Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
        • Contact:
      • Madrid, Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
        • Contact:
    • Valencia
      • Valencia, Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
        • Contact:
  • Sweden
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 75185
        • Uppsala University Hospital
        • Contact:
  • Switzerland
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Switzerland, 4031
  • United Kingdom
    • England
      • London, England, United Kingdom, EC1A 7BE
        • Barts Heart Centre, St Bartholomew's Hospital
        • Contact:
          • Andreas Baumbach, MD
          • Phone Number: +44 20 3765 8000
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

All participants for this study must meet all of the following inclusion criteria:

  1. Participants with ≥ 65 years of age.
  2. Participant has provided written informed consent as approved Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Ethics Committee (EC) of the investigational site to participate in the study.

  3. Participant with moderate aortic stenosis, defined as one of the following

    • Peak aortic jet velocity (Vmax) ≥ 3.0 m/s and < 4.0 m/s, or
    • Mean pressure gradient ≥ 25 mmHg and < 40 mmHg AND

    The participant must meet one of the following categories:

    3.1.AVA > 1.0 - ≤ 1.5 cm²; OR

    3.2.AVA ≤ 1.0 cm² (or AVAi ≤ 0.6 cm²/m²)

    3.2.1 Left Ventricular Function and Flow Profile: It is defined as participants with peak aortic jet velocity (Vmax) ≥ 3.0 and < 4.0 m/s or mean pressure gradient ≥ 25 and < 40 mmHg, and in the presence of aortic valve area (AVA) ≤ 1.0 cm² (or AVAi ≤ 0.6 cm²/m²)

    The participant must meet one of the following categories:

    a.Normal-Flow, Preserved LVEF:*

    • Stroke Volume Index (SVi > 35 ml/m²) and LVEF ≥ 50% then, perform CT aortic valve calcium score to confirm true moderate AS:<1200 AU (female) or < 2000 AU (male) OR b.Low-Flow, Preserved LVEF:
    • SVi ≤ 35 ml/m² and LVEF ≥ 50%, then perform CT aortic valve calcium score to confirm true moderate AS: < 1200 AU (female) or < 2000 AU (male) OR c.Low-Flow, Reduced LVEF:

    • SVi ≤ 35 ml/m² and LVEF < 50%, then confirm contractile reserve on dobutamine stress echocardiography (DSE)^, defined as a ≥ 20% increase in stroke volume with; I.AVA > 1.0 and ≤ 1.5 cm² or II.AVA > 1.0 cm² then perform CT aortic valve calcium score to confirm true moderate AS: < 1200 AU (female) or < 2000 AU (male) ^ If DSE is not feasible or inconclusive, CT calcium scoring will be considered, with thresholds of < 1200 AU for female and < 2000 AU for male to identify Moderate AS participants.

      • Not applicable for asymptomatic participants as asymptomatic with SVi > 35 are excluded.

  4. Moderate AS participants with symptoms:

    1. Evidence of symptoms:

      I.NYHA class ≥ II# and II.Chronic Dyspnea or III.Angina (CCS ≥ II) or IV.Cardiac Syncope

      OR

    2. Asymptomatic moderate AS participants with at least one of the evidence of cardiac damage/dysfunction:

I.Participant with left ventricle ejection fraction ≤ 50% or

II.Diastolic dysfunction ≥ Grade II or

III.Stroke Volume Index ≤ 35 ml/m² or

IV.Persistent Atrial Fibrillation (AF) lasting from past 6 months or Paroxysmal Atrial Fibrillation episode within 6 months prior to consent or

V.NT-proBNP ≥ 200 pg/ml or ng/l or ≥ 200000 µg/l (or BNP ≥ 50 pg/ml or ng/l or ≥ 50000 µg/l) or

VI.LV mass index > 95 g/m² for female and > 115 g/m² for male (To detect LV hypertrophy) or

VII.LV dimension or

  1. LV systolic diameter > 4 cm or > 40 mm for male and > 3.5 cm or 35 mm for female or
  2. LV diastolic diameter > 5.8 cm or > 58 mm for male and > 5.2 cm or 52 mm for female

VIII.LV volume

  1. LV systolic volume > 61 mL or cm3 for male and > 42 mL or cm3 for female or

  2. LV diastolic volume > 150 mL or cm3 for male and > 106 mL or cm3 for female

    • Only 10% of total study participants with NYHA class IV will be included in the trial.

Exclusion Criteria:

  1. Participants with moderate aortic stenosis undergoing concomitant CABG or surgical intervention on the ascending aorta or another valve.
  2. Aortic valve is unicuspid or non-calcified as verified by echocardiography/CT.
  3. Renal insufficiency with glomerular filtration rate (GFR) < 30 mL/min and/or need for renal replacement therapy.
  4. Participants with ≥ moderate concomitant aortic regurgitation (≥ 3 grade).
  5. Participants with severe aortic stenosis.
  6. Moderate or severe mitral/tricuspid regurgitation (≥ 3 grade).
  7. Participants with pre-existing mechanical or bioprosthetic aortic valve.
  8. Left ventricle ejection fraction ≤ 20%.
  9. Severe left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVI.
  10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.
  11. Previous stroke with permanent disability (modified Rankin score ≥ 2).
  12. Life expectancy < 24 months due to non-cardiac co-morbid conditions including carcinomas, chronic liver disease, chronic renal disease or chronic end-stage pulmonary disease.
  13. Currently participating in an investigational drug or another device study where the primary endpoint is not achieved.
  14. Any condition, which in the Investigator's opinion, would preclude safe participation of participants in the study (e.g. psychiatric, alcoholism).
  15. TAVI unsuitable via transfemoral route.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcatheter Aortic Valve Implantation
Device: Transcatheter aortic valve Implantation
Myval THV Series will include Myval/Myval Octacor/ OctaPro/OctaPro+ THV or any subsequent advanced version commercially available at the investigator site.
No Intervention: Guideline-directed medical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Efficacy Endpoint
Time Frame: 2-year

It is the composite of following:

All-cause mortality,

Disabling stroke,

Aortic valve replacement due to advanced valve syndrome (AVS),

Heart failure hospitalization,

Deterioration in quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 2 years or at the time of conversion to AVR in the GDMT arm.
2-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: Predischarge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 4- year, 5-year, 6-year, 7-year and 10-year
As per VARC-3 defined criteria
Predischarge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 4- year, 5-year, 6-year, 7-year and 10-year
All stroke
Time Frame: Pre-discharge, 30- day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
As per VARC-3 defined criteria
Pre-discharge, 30- day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Acute Kidney Injury (AKI)
Time Frame: Pre-discharge, 30-day
As per VARC-3 defined criteria
Pre-discharge, 30-day
Bleeding (Type 2, 3 and 4)
Time Frame: Predischarge, 30-day
As per VARC-3 defined criteria
Predischarge, 30-day
Major vascular complications
Time Frame: 30-day
As per VARC-3 defined criteria
30-day
Conduction disturbances and arrhythmias
Time Frame: Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5- year, 3-year and 5-year
As per VARC-3 defined criteria
Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5- year, 3-year and 5-year
New Permanent Pacemaker Implantation (PPI)
Time Frame: Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
As per VARC-3 defined criteria
Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Proportion of participants requiring initiation of Cardiac Resynchronization Therapy
Time Frame: Pre-discharge, 30-day, 6- month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Initiation of CRT (Cardiac Resynchronization Therapy Pacemaker or Defibrillator with Cardiac Resynchronization Therapy) as clinically indicated by the treating cardiologist.
Pre-discharge, 30-day, 6- month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Aortic valve replacement due to advanced valve syndrome
Time Frame: 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Myocardial Infarction
Time Frame: Predischarge, 30-day, 6-month, 1-year, 1.5-year, 2-year
As per VARC-3 defined criteria
Predischarge, 30-day, 6-month, 1-year, 1.5-year, 2-year
New York Heart Association (NYHA) functional classification
Time Frame: Screening, Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2- year, 2.5-year, 3-year and 5-year
Screening, Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2- year, 2.5-year, 3-year and 5-year
Six-minute walk test
Time Frame: Screening, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Screening, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Echocardiographic endpoints
Time Frame: Screening, Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10- year
Screening, Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10- year
Bioprosthetic valve failure
Time Frame: 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
VARC-3 defined criteria
1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
Bioprosthetic valve deterioration
Time Frame: 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
VARC-3 defined criteria
1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
Aortic bioprosthetic valve dysfunction
Time Frame: 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
As per VARC-3 defined criteria
1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
Heart failure hospitalization
Time Frame: 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
As per VARC-3 defined criteria
30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Kansas City Cardiomyopathy Questionnaire
Time Frame: Screening, 1-year, 2-year, At time of conversion to AVR from GDMT arm

Overall Summary Score < 45 or decline from baseline of >10 point (Unfavorable Outcome)

Score Interpretation:

0 to 25: Very poor to poor health 25 to 49: Poor to fair health 50 to 74: Fair to good health 75 to 100: Good to excellent health
Screening, 1-year, 2-year, At time of conversion to AVR from GDMT arm
Moderate or severe prosthetic valve regurgitation
Time Frame: Screening, Pre-discharge, 30-day, 6-month, 1- year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
As per VARC-3 defined criteria
Screening, Pre-discharge, 30-day, 6-month, 1- year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP) or BNP
Time Frame: Screening, Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Screening, Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
New onset of atrial fibrillation or atrial flutter
Time Frame: Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
As per VARC-3 defined criteria
Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Aortic valve replacement or reintervention
Time Frame: 30-day, 6- month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
Aortic valve replacement or reintervention is defined as any surgical or transcatheter procedure performed to replace the native aortic valve with a prosthetic valve or to treat dysfunction of a previously implanted prosthetic aortic valve. This includes surgical aortic valve replacement (SAVR), transcatheter aortic valve implantation (TAVI), valve-in-valve TAVI, redo TAVI, or surgical replacement of a previously implanted transcatheter or surgical valve.
30-day, 6- month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
Technical success
Time Frame: At exit from procedure room
As per VARC-3 defined criteria
At exit from procedure room
Device success
Time Frame: 30-day
As per VARC-3 defined criteria
30-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meril Life Sciences Pvt. Ltd.

Investigators

  • Study Director: Prof. Patrick Serruys, MD, PhD, FACC, FESC, National University of Ireland, Galway, Ireland
  • Study Chair: Prof. Andreas Baumbach, MD, FESC, FRCP, Barts Heart Center, London, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 17, 2026

Primary Completion (Estimated)

May 12, 2031

Study Completion (Estimated)

May 12, 2041

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLS/MYV/LANDMARK 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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