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Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure

Primary Purpose

Congestive Heart Failure, Type II Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
vildagliptin
placebo of vildagliptin
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Congestive Heart Failure, CHF, vildagliptin, metabolic disease, cardiovascular disease, T2DM

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with T2DM, diagnosed at least 3 months prior to Visit 1
  • CHF (NYHA Class I, Class II, or Class III) at Visit 1
  • LVEF < 40%

Exclusion Criteria:

  • Pregnant or lactating female
  • FPG ≥ 270 mg/dL (≥15 mmol/L)

Sites / Locations

  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vildagliptin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF).

Secondary Outcome Measures

To evaluate the overall safety of vildagliptin versus placebo in patients with T2DM and CHF (NYHA class I - III) over 52 weeks of treatment with special regard to signs and symptoms of heart failure.
To evaluate the efficacy of vildagliptin in patients with T2DM and CHF (NYHA class I-III) by assessing the HbA1c reduction with vildagliptin compared to placebo after 16 weeks of treatment.

Full Information

First Posted
May 6, 2009
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00894868
Brief Title
Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure
Official Title
A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of 52 Weeks Treatment With Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This study will assess the effect of vildagliptin on left ventricular function in patients with type 2 diabetes and congestive heart failure (NYHA Class I-III). Effect on HbA1c and overall safety and tolerability will also be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Type II Diabetes Mellitus
Keywords
Congestive Heart Failure, CHF, vildagliptin, metabolic disease, cardiovascular disease, T2DM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
798 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vildagliptin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
vildagliptin
Intervention Type
Drug
Intervention Name(s)
placebo of vildagliptin
Primary Outcome Measure Information:
Title
To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF).
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
To evaluate the overall safety of vildagliptin versus placebo in patients with T2DM and CHF (NYHA class I - III) over 52 weeks of treatment with special regard to signs and symptoms of heart failure.
Time Frame
52 weeks
Title
To evaluate the efficacy of vildagliptin in patients with T2DM and CHF (NYHA class I-III) by assessing the HbA1c reduction with vildagliptin compared to placebo after 16 weeks of treatment.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with T2DM, diagnosed at least 3 months prior to Visit 1 CHF (NYHA Class I, Class II, or Class III) at Visit 1 LVEF < 40% Exclusion Criteria: Pregnant or lactating female FPG ≥ 270 mg/dL (≥15 mmol/L)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Benesov
State/Province
Czech Republic
ZIP/Postal Code
25601
Country
Czechia
Facility Name
Novartis Investigative Site
City
Havirov
State/Province
Czech Republic
ZIP/Postal Code
736 01
Country
Czechia
Facility Name
Novartis Investigative Site
City
Litomysl
State/Province
Czech Republic
ZIP/Postal Code
570 14
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha 4
State/Province
Czech Republic
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha 2
State/Province
CZE
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Novartis Investigative Site
City
Broumov
ZIP/Postal Code
550 01
Country
Czechia
Facility Name
Novartis Investigative Site
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Facility Name
Novartis Investigative Site
City
Copenhagen NV
ZIP/Postal Code
DK-2400
Country
Denmark
Facility Name
Novartis Investigative Site
City
Copenhagen S
ZIP/Postal Code
DK-2300
Country
Denmark
Facility Name
Novartis Investigative Site
City
Frederiksberg
ZIP/Postal Code
DK-2000
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Denmark
Facility Name
Novartis Investigative Site
City
Hellerup
ZIP/Postal Code
DK-2900
Country
Denmark
Facility Name
Novartis Investigative Site
City
Roskilde
ZIP/Postal Code
DK-4000
Country
Denmark
Facility Name
Novartis Investigative Site
City
Slagelse
ZIP/Postal Code
DK-4200
Country
Denmark
Facility Name
Novartis Investigative Site
City
Pärnu
ZIP/Postal Code
80018
Country
Estonia
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
13415
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Estonia
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Novartis Investigative Site
City
Tartu
ZIP/Postal Code
50410
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Estonia
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Novartis Investigative Site
City
Alsdorf
ZIP/Postal Code
52477
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Germany
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Novartis Investigative Site
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Bad Oeynhausen
ZIP/Postal Code
32545
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Germany
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Novartis Investigative Site
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Dresden
ZIP/Postal Code
01307
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Germany
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Novartis Investigative Site
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Fulda
ZIP/Postal Code
36037
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Germany
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Novartis Investigative Site
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Kamp-Lintfort
ZIP/Postal Code
47475
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Germany
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Novartis Investigative Site
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Saarlouis
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66740
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Germany
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Novartis Investigative Site
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Senden
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48308
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Germany
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Novartis Investigative Site
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Alexandroupolis
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GR 68100
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Greece
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Novartis Investigative Site
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Chios
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82100
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Greece
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Novartis Investigative Site
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Thessaloniki
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57001
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Greece
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Novartis Investigative Site
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Guatemala City
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01010
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Guatemala
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Novartis Investigative Site
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Guatemala City
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01011
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Guatemala
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Novartis Investigative Site
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Secunderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500003
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India
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Novartis Investigative Site
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Visakhapatnam
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Andhra Pradesh
ZIP/Postal Code
530002
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India
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Novartis Investigative Site
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Vishakhapatnam
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Andhra Pradesh
ZIP/Postal Code
530002
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India
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Novartis Investigative Site
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New Delhi
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Delhi
ZIP/Postal Code
110070
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India
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Novartis Investigative Site
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Ahmedabad
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Gujarat
ZIP/Postal Code
380014
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India
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Novartis Investigative Site
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Vadodara
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Gujrat
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390015
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India
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Novartis Investigative Site
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Bangalore
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Karnataka
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560078
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India
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Novartis Investigative Site
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Mangalore
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Karnataka
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575002
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India
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Novartis Investigative Site
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Trivandrum
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Kerala
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695011
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India
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Novartis Investigative Site
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Indore
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Madhya Pradesh
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452010
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India
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Novartis Investigative Site
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Nagpur
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Maharashtra
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440012
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India
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Novartis Investigative Site
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Ludhiana
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Punjab
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141001
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India
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Novartis Investigative Site
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Jaipur
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Rajasthan
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302001
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India
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Novartis Investigative Site
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Lucknow
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Uttar Pradesh
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226003
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India
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Novartis Investigative Site
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Bergamo
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BG
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24128
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Italy
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Novartis Investigative Site
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Firenze
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FI
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50143
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Italy
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Novartis Investigative Site
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Milano
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MI
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20132
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Italy
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Novartis Investigative Site
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Passirana Di Rho
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MI
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20017
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Italy
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Novartis Investigative Site
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Pavia
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PV
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Italy
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Novartis Investigative Site
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Mercato San Severino
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SA
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84085
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Italy
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Novartis Investigative Site
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Siena
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SI
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53100
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Italy
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Novartis Investigative Site
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Novara
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28100
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Italy
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Daugavpils
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LV-5401
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Latvia
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Novartis Investigative Site
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Preili
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LV-5301
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Latvia
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Alytus
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LT-62381
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Lithuania
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Novartis Investigative Site
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Kaunas
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50009
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Lithuania
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Novartis Investigative Site
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Vilnius
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LT-05261
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Lithuania
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Novartis Investigative Site
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Vilnius
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LT-08661
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Lithuania
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Novartis Investigative Site
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Gdansk
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80-847
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Poland
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Novartis Investigative Site
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Klodzko
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57-300
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Poland
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Novartis Investigative Site
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Warsawa
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Poland
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Novartis Investigative Site
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Wroclaw
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50-981
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Poland
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Novartis Investigative Site
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Bucharest
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District 2
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021382
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Romania
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Novartis Investigative Site
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Craiova
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Jud. Dolj
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200147
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Romania
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Novartis Investigative Site
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Baia-Mare
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Maramures
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430071
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Romania
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Novartis Investigative Site
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Brasov
ZIP/Postal Code
500173
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Romania
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Novartis Investigative Site
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Kaliningrad
ZIP/Postal Code
236016
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Russian Federation
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Novartis Investigative Site
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Kazan
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420012
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Russian Federation
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Novartis Investigative Site
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Krasnodar
ZIP/Postal Code
350072
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Russian Federation
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Novartis Investigative Site
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Moscow
ZIP/Postal Code
113093
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Russian Federation
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Novartis Investigative Site
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Moscow
ZIP/Postal Code
117997
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Russian Federation
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Novartis Investigative Site
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Moscow
ZIP/Postal Code
119048
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Russian Federation
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Novartis Investigative Site
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Moscow
ZIP/Postal Code
121552
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Russian Federation
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Novartis Investigative Site
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Moscow
ZIP/Postal Code
127473
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Russian Federation
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Novartis Investigative Site
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Moscow
ZIP/Postal Code
129110
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Russian Federation
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Novartis Investigative Site
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N.Novgorod
ZIP/Postal Code
603126
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Russian Federation
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Novartis Investigative Site
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Nizhny Novgorod
ZIP/Postal Code
603018
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Russian Federation
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Novartis Investigative Site
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Penza
ZIP/Postal Code
440026
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Russian Federation
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Novartis Investigative Site
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Petrozavodsk
ZIP/Postal Code
185019
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Russian Federation
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Novartis Investigative Site
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Saint-Petersburg
ZIP/Postal Code
193312
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Russian Federation
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Novartis Investigative Site
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Saint-Petersburg
ZIP/Postal Code
197341
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Russian Federation
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Novartis Investigative Site
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Samara
ZIP/Postal Code
443067
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Russian Federation
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Novartis Investigative Site
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Saratov
ZIP/Postal Code
410012
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Russian Federation
Facility Name
Novartis Investigative Site
City
Saratov
ZIP/Postal Code
410031
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Russian Federation
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Novartis Investigative Site
City
St. Petersburg
ZIP/Postal Code
198013
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Russian Federation
Facility Name
Novartis Investigative Site
City
St.- Petersburg
ZIP/Postal Code
199034
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Russian Federation
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
119074
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Singapore
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
168752
Country
Singapore
Facility Name
Novartis Investigative Site
City
Dunajska Streda
State/Province
Slovak Republic
ZIP/Postal Code
929 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Nitra
State/Province
Slovak Republic
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Novartis Investigative Site
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Banska Bystrica
ZIP/Postal Code
974 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Komarno
ZIP/Postal Code
945 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Lucenec
ZIP/Postal Code
98439
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Modava Nad Bodvou
ZIP/Postal Code
045 01
Country
Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
29032139
Citation
McMurray JJV, Ponikowski P, Bolli GB, Lukashevich V, Kozlovski P, Kothny W, Lewsey JD, Krum H; VIVIDD Trial Committees and Investigators. Effects of Vildagliptin on Ventricular Function in Patients With Type 2 Diabetes Mellitus and Heart Failure: A Randomized Placebo-Controlled Trial. JACC Heart Fail. 2018 Jan;6(1):8-17. doi: 10.1016/j.jchf.2017.08.004. Epub 2017 Oct 11.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=9563
Description
Results for CLAF237A23118 from the Novartis Clinical Trials website

Learn more about this trial

Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure

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