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Clinical trials for Ertugliflozin

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44347   clinical trials with a EudraCT protocol, of which   7375   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    13 result(s) found for: Ertugliflozin. Displaying page 1 of 1.
    EudraCT Number: 2013-003698-82 Sponsor Protocol Number: MK8835-005 Start Date*: 2014-07-09
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Ertugliflozin (MK-8835/PF-04971729) with Sitagliptin Compared with Ertugliflozin A...
    Medical condition: Treatment of type 2 diabetes mellitus (T2DM) and inadequate glycemic control on treatment with metformin.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004861 10063624 Type II diabetes mellitus inadequate control LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) IT (Completed) GB (Completed) FI (Completed) SK (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-001049-25 Sponsor Protocol Number: MK8835-017 Start Date*: 2014-12-16
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Initial Combination of Ertugliflozin (MK-8835/PF-049...
    Medical condition: Treatment of type 2 diabetes mellitus (T2DM) with Inadequate Glycemic Control on Diet and Exercise
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004861 10063624 Type II diabetes mellitus inadequate control LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) GB (Completed) CZ (Completed) EE (Completed) BG (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2013-003697-26 Sponsor Protocol Number: MK8835-006 Start Date*: 2014-07-23
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in the Treatment of ...
    Medical condition: Treatment of type 2 diabetes mellitus (T2DM) and inadequate glycemic control on treatment with metformin and sitagliptin.
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004861 10063624 Type II diabetes mellitus inadequate control LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) SK (Completed) FI (Completed) BG (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2020-002581-14 Sponsor Protocol Number: DvL-2020-01 Start Date*: 2020-11-04
    Sponsor Name:Medical University of Graz, Division of Cardiology
    Full Title: Ertugliflozin to Reduce Arrhythmic burden in ICD/CRT patientS (ERASe-Trial) – a phase III Study
    Medical condition: Heart failure
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-005474-25 Sponsor Protocol Number: DC2021DESIGN1 Start Date*: 2023-08-03
    Sponsor Name:VUmc – Internal medicine / Diabetes Center
    Full Title: DiEtary Sodium Intake effects on ertugliflozin-induced changes in GFR, reNal oxygenation and systemic hemodynamics: the DESIGN study, a randomized, placebo-controlled, cross-over study with ertugli...
    Medical condition: Type 2 Diabetes Mellitus
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003455-35 Sponsor Protocol Number: MK-8835-059 Start Date*: 2019-09-26
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
    Full Title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in Pediatric Participants (ages 10 to ...
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Trial now transitioned) PL (Trial now transitioned) FR (Prematurely Ended) BE (Completed) Outside EU/EEA IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-003587-31 Sponsor Protocol Number: MK8835-001 Start Date*: 2014-04-03
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) in Subjects with Type 2 Diabetes Mel...
    Medical condition: Type 2 Diabetes Mellitus with Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Background Antihyperglycemic Therapy
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004861 10063624 Type II diabetes mellitus inadequate control LLT
    18.0 100000004857 10045250 Type II diabetes mellitus with renal manifestations LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) BG (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2013-003582-34 Sponsor Protocol Number: MK8835-002 Start Date*: 2014-05-29
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Ertugliflozin (MK-8835/PF-04971729) Compared With...
    Medical condition: Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metaformin
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004861 10063624 Type II diabetes mellitus inadequate control LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) LT (Completed) HU (Completed) SK (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2013-002519-90 Sponsor Protocol Number: 8835-003 Start Date*: 2014-02-14
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study with a 26-Week Extension to Evaluate the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Subj...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    18.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-001840-37 Sponsor Protocol Number: 2017-001840-37 Start Date*: 2019-01-15
    Sponsor Name:VU University Medical Center
    Full Title: ERtugliflozin triAl in DIabetes with preserved or reduced ejeCtion FrAcTion mEchanistic evaluation in Heart Failure: "ERADICATE-HF"
    Medical condition: Diabetes Mellitus Type 2 and Heart failure
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-003290-95 Sponsor Protocol Number: 8835-007 Start Date*: 2014-04-09
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 26-WEEK MULTICENTER STUDY WITH A 78-WEEK EXTENSION TO EVALUATE THE EFFICACY AND SAFETY OF ERTUGLIFLOZIN IN SUBJECTS WITH TYPE 2 DIABETES MEL...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    18.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) SK (Completed) CZ (Completed) PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2013-002518-11 Sponsor Protocol Number: 8835-004 Start Date*: 2014-01-16
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS CARDIOVASCULAR OUTCOMES FOLLOWING TREATMENT WITH ERTUGLIFLOZIN (MK-8835/PF-04971729) IN SUBJECTS WITH TYPE 2 DIABETES ME...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) NL (Completed) GB (Completed) IT (Completed) ES (Completed) BG (Completed) PL (Completed) GR (Completed) HR (Completed) SK (Completed) LT (Completed) LV (Completed) CZ (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2019-000730-19 Sponsor Protocol Number: DC2019ROCKIES1 Start Date*: 2020-03-05
    Sponsor Name:Amsterdam Univeristy Medical Center - Vu Univeristy Medical Center
    Full Title: A phase 4, monocenter, prospective, randomized, placebo-controlled, double-blind, cross-over mechanistic intervention trial to assess effect of 4-week Ertugliflozin (SGLT-2 inhibitor) therapy on re...
    Medical condition: Type 2 Diabetes Mellitus
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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