1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00153023
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 13, 2013
Information provided by:
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathies Hypertension Drug: Telmisartan Drug: Valsartan Phase 4

Detailed Description:

This is a randomised, double-blind, double-dummy, forced titration, multicentre, parallel group trial in patients with essential hypertension, diabetes mellitus type 2 and diabetic nephropathy.

After a 4-6 week Run-in period, patients are randomised to one of the treatment groups and receive either Telmisartan 40 - 80 mg or Valsartan 80 - 160 mg. The treatment regimen is a forced titration with the lower dose given for 2 weeks and the higher dose given for the rest of the treatment period summing up to 52 weeks of treatment. During the treatment period, 8 visits to the investigator are scheduled in order to control blood pressure, renal function parameters and safety. In addition, parameters of endothelial function and oxidative stress are measured at baseline, 6 months and after one year of treatment.

Study Hypothesis:

Non-inferiority of telmisartan 80 mg compared to valsartan 160 mg will be tested using the following set of hypotheses:

Null Hypothesis:

The overall mean change from baseline in UPER (24 hour urinary protein excretion rate) for telmisartan 80 mg is inferior to that for valsartan 160 mg by 0.5 g/day or more.

Alternative Hypothesis:

The overall mean change from baseline in UPER (24 hour urinary protein excretion rate) for telmisartan 80 mg is less than 0.5 g/day worse than that for valsartan 160 mg.


In order to test the non-inferiority hypothesis, analysis of covariance with treatment and centre as main effects and baseline as a covariate will be performed. Time-to-event data will be analysed using the log-rank test.

Study Type : Interventional  (Clinical Trial)
Enrollment : 885 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2003
Actual Primary Completion Date : December 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Primary Outcome Measures :
  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. [ Time Frame: Baseline, after 1 year of treatment ]

Secondary Outcome Measures :
  1. Change from baseline in 24-hour urinary albumin excretion rate (UAER). [ Time Frame: Baseline, after 1 year of treatment ]
  2. Change from baseline in 24-hour urinary sodium excretion rate. [ Time Frame: Baseline, after 1 year of treatment ]
  3. Change from baseline in serum creatinine. [ Time Frame: Baseline, after 1 year of treatment ]
  4. Change from baseline in creatinine clearance [ Time Frame: Baseline, after 1 year of treatment ]
  5. Change from baseline in estimated glomerular filtration rate (eGFR). [ Time Frame: Baseline, after 1 year of treatment ]
  6. Change from baseline in plasma asymmetrical dimethylarginine (ADMA) levels. [ Time Frame: Baseline, after 1 year of treatment ]
  7. Change from baseline in urine 8-iso-prostaglandin F2α levels [ Time Frame: Baseline, after 1 year of treatment ]
  8. Change from baseline in serum high sensitive C-reactive protein (CRP) levels. [ Time Frame: Baseline, after 1 year of treatment ]
  9. Time to a composite of a doubling of serum creatinine concentration , end-stage renal disease (ESRD), or all cause death [ Time Frame: after 1 year of treatment ]
  10. Time to a composite of morbidity and mortality from cardiovascular causes (myocardial infarction (MI), stroke, first hospitalisation for heart failure or unstable angina, coronary or peripheral revascularisation). [ Time Frame: after 1 year of treatment ]
  11. Change from baseline in insulin sensitivity (Homeostasis Model Assessment (HOMA) index). [ Time Frame: Baseline, after 1 year of treatment ]
  12. Change from baseline in plasma adiponectin levels. [ Time Frame: Baseline, after 1 year of treatment ]
  13. Change from baseline in BP endpoints (SBP, DBP and pulse pressure) [ Time Frame: Baseline, after 1 year of treatment ]

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Type 2 diabetes mellitus
  2. Aged 30-70 years of age
  3. 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)
  4. Overt nephropathy defined by 24 hour proteinuria >= 900 mg and by serum creatinine below 265 mol/l (3.0 mg/dl)

Exclusion Criteria: None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00153023

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Czech Republic
University Hospital St. Anna
Brno, Czech Republic, 656 91
University Hospital Hradec Kralove
Hradec Kralove, Czech Republic, 500 05
University Hospital Vihohrady
Prague 10, Czech Republic, 100 34
General University Hospital
Prague 2, Czech Republic, 128 08
District Hospital Tabor
Tabor, Czech Republic, 390 03
Masaryk Hospital
Usti nad Labem, Czech Republic, 401 13
Hospital Usti nad Orlici
Usti nad Orlici, Czech Republic, 562 18
Medical Department
Copenhagen NV, Denmark, DK-2400
Medicinsk afdeling
Fredericia, Denmark, DK-7000
Medicinsk afdeling F, Endokrinologisk
Hiller?d, Denmark, 3400
Endokrinologisk afdeling
Hvidovre, Denmark, DK-2650
Medical Department
Roskilde, Denmark, DK-4000
Chu Sud
Amiens, France, 80054
Centre Hospitalier
Beauvais, France, 60021
Hopital Duchenne
Boulogne sur Mer cedex, France, 62320
Hopital Clemenceau
Caen cedex 5, France, 14033
Centre Hospitalier
Dunkerque, France, 59240
Hopital Albert Michalon
La Tronche, France, 38700
Hopital A.Mignot
Le Chesnay, France, 78157
Hopital Maison Blanche
Reims, France, 51100
Hopital Yves Le Foll
Saint Brieuc cedex 1, France, 22023
Hopital Saint Quentin
Saint Quentin, France, 02100
Centre Hospitalier
Valenciennes, France, 59322
Boehringer Ingelheim Investigational Site
Aschaffenburg, Germany, 63739
Diabetes Klinik Bad Mergentheim
Bad Mergentheim, Germany, 97980
Institut fur Klinische Forschung
Berlin, Germany, 10115
Charite Campus Buch
Berlin, Germany, 13125
KFH Dialysezentrum
Eberswalde, Germany, 16225
Universitatsklinik Heidelberg
Heidelberg, Germany, 69115
Boehringer Ingelheim Investigational Site
Karlsruhe, Germany, 76133
Institut fur Klinische Forschung
Mainz, Germany, 55116
Boehringer Ingelheim Investigational Site
Munster, Germany, 48145
Boehringer Ingelheim Investigational Site
Neuwied, Germany, 56564
Boehringer Ingelheim Investigational Site
Pirna, Germany, 01796
Boehringer Ingelheim Investigational Site
Riesa, Germany, 01587
Boehringer Ingelheim Investigational Site
Rosenheim, Germany, 83022
Boehringer Ingelheim Investigational Site
Saarbrucken, Germany, 66121
Boehringer Ingelheim Investigational Site
Saarlouis, Germany, 66740
Boehringer Ingelheim Investigational Site
Sinsheim, Germany, 74889
Boehringer Ingelheim Investigational Site
Speyer, Germany, 67346
Wurzburg, Germany, 97072
Azienda Ospedaliera Policlinico S. Orsola Malpighi
Bologna, Italy, 40138
Ospedali Riuniti di Livorno
Livorno, Italy, 57100
Presidio Ospedaliero Campo di Marte
Lucca, Italy, 55100
Universita degli Studi "Federico II"
Napoli, Italy, 80131
Azienda Ospedaliera di Padova
Padova, Italy, 35128
IRCCS Policlinico S.Matteo
Pavia, Italy, 27100
Policlinico Monteluce
Perugia, Italy, 06100
Azienda Ospedaliera S. Maria degli Angeli
Pordenone, Italy, 33170
Ospedale "S. Maria delle Croci"
Ravenna, Italy, 48100
Universita Tor Vergata
Roma, Italy, 00133
Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of, 700712
Yonsei University Medical Center
Seoul, Korea, Republic of
Hospital Ipoh
Ipoh, Perak, Malaysia, 30990
University Sains Malaysia
Kelantan, Malaysia, 16150
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Kuala Lumpur, Malaysia, 50586
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Penang General Hospital
Penang, Malaysia
Hospital Putrajaya
Selangor, Malaysia
Centro Hospitalar de Coimbra
Coimbra, Portugal, 3041.853
Hospital Distrital de Faro
Faro, Portugal, 8000-386
Hospital de Santa Maria
Lisboa, Portugal, 1169-024
Hospital de Santa Marta
Lisboa, Portugal, 1169-024
Associac?o Protectora dos Diabeticos de Portugal
Lisboa, Portugal, 1250
Hospital Curry Cabral
Lisbon, Portugal, 1050-035
Hospital Pedro Hispano
Matosinhos, Portugal, 4460-301
Hospital de S. Jo?o
Porto, Portugal, 4200
Centro Hospitalar Vila Nova de Gaia
Vila Nova de Gaia, Portugal, 4434-502
Russian Federation
Medical Academy named Sechenova I.M.
Moscow, Russian Federation, 103030
Russian State Medical University
Moscow, Russian Federation, 107066
Russian State Medical University
Moscow, Russian Federation, 115516
National Endocrinology Research Center of Russia
Moscow, Russian Federation, 117036
Russian State Medical University
Moscow, Russian Federation, 117485
President's Medical Center
Moscow, Russian Federation, 121356
Russian Cardiology Research Center
Moscow, Russian Federation, 121552
Russian Academy for Advanced Medical Studies
Moscow, Russian Federation, 125315
Moscow President's Medical Center
Moscow, Russian Federation, 129090
Regional Clinical Scientific Research Institute
Moscow, Russian Federation, 129110
City Hospital of Saint Elizaveta
St. Petersburg, Russian Federation, 195257
Military Medical Academy
St. Petersburg, Russian Federation, 198013
Banska Bystrica, Slovakia, 974 05
Ministry Hospital of Internal Affairs
Bratislava, Slovakia, 812 72
Faculty Hospital
Bratislava, Slovakia, 81369
Faculty Hospital of L. Derer
Bratislava, Slovakia, 833 05
Diabetologic and Internal Clinic
Lucenec, Slovakia, 984 01
Faculty Hospital
Nitra, Slovakia, 94901
Hospital Nove Mesto
Nove Mesto, Slovakia, 915 01
Regional Hospital Nove Zamky
Nove Zamky, Slovakia, 940 52
Trencin, Slovakia, 91101
Faculty Hospital Trnava
Trnava, Slovakia, 91701
Hospital Torrecardenas
Almeria, Spain, 04009
Hospital Ntra. Sra de Sonsoles
Avila, Spain, 05071
Hospital Clinico y Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Vall d'Hebron
Barcelona, Spain, 08038
Hospital de Basurto
Bilbao, Spain, 48013
Hospital Universitario Reina Sofia
Cordoba, Spain, 14004
Hospital de Cabuenes
Gijon, Spain, 33204
Hospital Virgen del Rocio
Sevilla, Spain, 41013
Hospital Universitario La Fe
Valencia, Spain, 46009
Changhua Christian Hospital
Changhua, Taiwan, 500
Buddhist Tzu Chi Hospital
Hualien City, Taiwan, 970
National Cheng Kung University Hospital
Tainan, Taiwan, 70428
Mackay Memorial Hospital
Taipei, Taiwan, 104
Chi Mei Medical Center
Taiwan, Taiwan, 701
Dnyepropyetrovsk Medical Academy
Dnyepropetrovsk, Ukraine, 49044
Kharkiv Medical State University
Kharkov, Ukraine, 61022
Institute of Diabetic pathology problems
Kharkov, Ukraine, 61070
Institute of Cardiology
Kiev, Ukraine, 03151
V.P. Komisarenko Institute of Endocrinology and Metabolism
Kiev, Ukraine, 04114
Kyiv Clinical Hospital No. 1
Kyiv, Ukraine, 02091
Zaporozhye Regional Clinical Hospital
Zaporozhye, Ukraine, 69600
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Pharma GmbH & Co. KG Identifier: NCT00153023     History of Changes
Other Study ID Numbers: 502.396
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action