1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy
A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Investigate the Efficacy of Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy VIVALDI-Study
1 other identifier
interventional
885
13 countries
111
Brief Summary
The general aim of this study is to compare telmisartan 80 mg with valsartan 160 mg in hypertensive patients with type 2 diabetes and overt nephropathy with adjusted blood pressure beyond the target of 130/80 mmHg after one year of treatment. The primary objective of this study is to show that telmisartan 80 mg is at least as effective (i.e., not inferior) and possibly superior to valsartan 160 mg in reducing 24 hour proteinuria after one year of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2003
Typical duration for phase_4
111 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedNovember 13, 2013
November 1, 2013
2.7 years
September 9, 2005
November 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline (Visit 6) in 24 hour proteinuria, after one year of treatment (study end) with telmisartan 80 mg versus valsartan 160 mg.
Baseline, after 1 year of treatment
Secondary Outcomes (13)
Change from baseline in 24-hour urinary albumin excretion rate (UAER).
Baseline, after 1 year of treatment
Change from baseline in 24-hour urinary sodium excretion rate.
Baseline, after 1 year of treatment
Change from baseline in serum creatinine.
Baseline, after 1 year of treatment
Change from baseline in creatinine clearance
Baseline, after 1 year of treatment
Change from baseline in estimated glomerular filtration rate (eGFR).
Baseline, after 1 year of treatment
- +8 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus
- Aged 30-70 years of age
- Hypertension at screening defined as:
- an average cuff systolic blood pressure \> 130 mmHg and/or diastolic blood pressure \>80 mmHg in untreated patients OR
- patients receiving antihypertensive therapy (i.e., medications specifically prescribed to treat hypertension)
- Overt nephropathy defined by 24 hour proteinuria \>= 900 mg and by serum creatinine below 265 mol/l (3.0 mg/dl)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (111)
University Hospital St. Anna
Brno, 656 91, Czechia
University Hospital Hradec Kralove
Hradec Králové, 500 05, Czechia
University Hospital Vihohrady
Prague, 100 34, Czechia
General University Hospital
Prague, 128 08, Czechia
District Hospital Tabor
Tábor, 390 03, Czechia
Masaryk Hospital
Ústí nad Labem, 401 13, Czechia
Hospital Usti nad Orlici
Ústí nad Orlicí, 562 18, Czechia
Medical Department
Copenhagen NV, DK-2400, Denmark
Medicinsk afdeling
Fredericia, DK-7000, Denmark
Medicinsk afdeling F, Endokrinologisk
Hiller?d, 3400, Denmark
Endokrinologisk afdeling
Hvidovre, DK-2650, Denmark
Medical Department
Roskilde, DK-4000, Denmark
Chu Sud
Amiens, 80054, France
Centre Hospitalier
Beauvais, 60021, France
Hopital Duchenne
Boulogne-sur-Mer, 62320, France
Hopital Clemenceau
Caen, 14033, France
Centre Hospitalier
Dunkirk, 59240, France
Hopital Albert Michalon
La Tronche, 38700, France
Hopital A.Mignot
Le Chesnay, 78157, France
Hopital Maison Blanche
Reims, 51100, France
Hopital Yves Le Foll
Saint-Brieuc, 22023, France
Hopital Saint Quentin
Saint-Quentin, 02100, France
Centre Hospitalier
Valenciennes, 59322, France
Boehringer Ingelheim Investigational Site
Aschaffenburg, 63739, Germany
Diabetes Klinik Bad Mergentheim
Bad Mergentheim, 97980, Germany
Institut fur Klinische Forschung
Berlin, 10115, Germany
Charite Campus Buch
Berlin, 13125, Germany
KFH Dialysezentrum
Eberswalde, 16225, Germany
Universitatsklinik Heidelberg
Heidelberg, 69115, Germany
Boehringer Ingelheim Investigational Site
Karlsruhe, 76133, Germany
Institut fur Klinische Forschung
Mainz, 55116, Germany
Boehringer Ingelheim Investigational Site
Münster, 48145, Germany
Boehringer Ingelheim Investigational Site
Neuwied, 56564, Germany
Boehringer Ingelheim Investigational Site
Pirna, 01796, Germany
Boehringer Ingelheim Investigational Site
Riesa, 01587, Germany
Boehringer Ingelheim Investigational Site
Rosenheim, 83022, Germany
Boehringer Ingelheim Investigational Site
Saarbrücken, 66121, Germany
Boehringer Ingelheim Investigational Site
Saarlouis, 66740, Germany
Boehringer Ingelheim Investigational Site
Sinsheim, 74889, Germany
Boehringer Ingelheim Investigational Site
Speyer, 67346, Germany
Internist
Würzburg, 97072, Germany
Azienda Ospedaliera Policlinico S. Orsola Malpighi
Bologna, 40138, Italy
Ospedali Riuniti di Livorno
Livorno, 57100, Italy
Presidio Ospedaliero Campo di Marte
Lucca, 55100, Italy
Universita degli Studi "Federico II"
Napoli, 80131, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
IRCCS Policlinico S.Matteo
Pavia, 27100, Italy
Policlinico Monteluce
Perugia, 06100, Italy
Azienda Ospedaliera S. Maria degli Angeli
Pordenone, 33170, Italy
Ospedale "S. Maria delle Croci"
Ravenna, 48100, Italy
Universita Tor Vergata
Roma, 00133, Italy
Penang General Hospital
George Town, Malaysia
Hospital Ipoh
Ipoh, Perak, 30990, Malaysia
University Sains Malaysia
Kelantan, 16150, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Hospital Putrajaya
Kuala Selangor, Malaysia
Centro Hospitalar de Coimbra
Coimbra, 3041.853, Portugal
Hospital Distrital de Faro
Faro, 8000-386, Portugal
Hospital Curry Cabral
Lisbon, 1050-035, Portugal
Hospital de Santa Maria
Lisbon, 1169-024, Portugal
Hospital de Santa Marta
Lisbon, 1169-024, Portugal
Associac?o Protectora dos Diabeticos de Portugal
Lisbon, 1250, Portugal
Hospital Pedro Hispano
Matosinhos Municipality, 4460-301, Portugal
Hospital de S. Jo?o
Porto, 4200, Portugal
Centro Hospitalar Vila Nova de Gaia
Vila Nova de Gaia, 4434-502, Portugal
Medical Academy named Sechenova I.M.
Moscow, 103030, Russia
Russian State Medical University
Moscow, 107066, Russia
Russian State Medical University
Moscow, 115516, Russia
National Endocrinology Research Center of Russia
Moscow, 117036, Russia
Russian State Medical University
Moscow, 117485, Russia
President's Medical Center
Moscow, 121356, Russia
Russian Cardiology Research Center
Moscow, 121552, Russia
Russian Academy for Advanced Medical Studies
Moscow, 125315, Russia
Moscow President's Medical Center
Moscow, 129090, Russia
Regional Clinical Scientific Research Institute
Moscow, 129110, Russia
City Hospital of Saint Elizaveta
Saint Petersburg, 195257, Russia
Military Medical Academy
Saint Petersburg, 198013, Russia
NovaMed
Banská Bystrica, 974 05, Slovakia
Ministry Hospital of Internal Affairs
Bratislava, 812 72, Slovakia
Faculty Hospital
Bratislava, 81369, Slovakia
Faculty Hospital of L. Derer
Bratislava, 833 05, Slovakia
Diabetologic and Internal Clinic
Lučenec, 984 01, Slovakia
Faculty Hospital
Nitra, 94901, Slovakia
Hospital Nove Mesto
Nové Mesto, 915 01, Slovakia
Regional Hospital Nove Zamky
Nové Zámky, 940 52, Slovakia
MSP-DIAGNOSTIK, Ltd.
Trenčín, 91101, Slovakia
Faculty Hospital Trnava
Trnava, 91701, Slovakia
Keimyung University Dongsan Medical Center
Daegu, 700712, South Korea
Yonsei University Medical Center
Seoul, South Korea
Hospital Torrecardenas
Almería, 04009, Spain
Hospital Ntra. Sra de Sonsoles
Ávila, 05071, Spain
Hospital Clinico y Provincial de Barcelona
Barcelona, 08036, Spain
Hospital Vall d'Hebron
Barcelona, 08038, Spain
Hospital de Basurto
Bilbao, 48013, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital de Cabuenes
Gijón, 33204, Spain
Hospital Virgen del Rocio
Seville, 41013, Spain
Hospital Universitario La Fe
Valencia, 46009, Spain
Changhua Christian Hospital
Changhua, 500, Taiwan
Chi Mei Medical Center
Dawan, 701, Taiwan
Buddhist Tzu Chi Hospital
Hualien City, 970, Taiwan
National Cheng Kung University Hospital
Tainan, 70428, Taiwan
Mackay Memorial Hospital
Taipei, 104, Taiwan
Dnyepropyetrovsk Medical Academy
Dnyepropetrovsk, 49044, Ukraine
Kharkiv Medical State University
Kharkiv, 61022, Ukraine
Institute of Diabetic pathology problems
Kharkiv, 61070, Ukraine
Institute of Cardiology
Kiev, 03151, Ukraine
V.P. Komisarenko Institute of Endocrinology and Metabolism
Kiev, 04114, Ukraine
Kyiv Clinical Hospital No. 1
Kyiv, 02091, Ukraine
Zaporozhye Regional Clinical Hospital
Zaporizhzhya, 69600, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
B.I. Pharma GmbH & Co. KG
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 12, 2005
Study Start
April 1, 2003
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
November 13, 2013
Record last verified: 2013-11