1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy
NCT ID: NCT00153023
Last Updated: 2013-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
885 participants
INTERVENTIONAL
2003-04-30
2005-12-31
Brief Summary
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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.
Detailed Description
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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.
Comparison(s):
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Telmisartan
Valsartan
Eligibility Criteria
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Inclusion Criteria
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)
30 Years
80 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
B.I. Pharma GmbH & Co. KG
Locations
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University Hospital St. Anna
Brno, , Czechia
University Hospital Hradec Kralove
Hradec Králové, , Czechia
University Hospital Vihohrady
Prague, , Czechia
General University Hospital
Prague, , Czechia
District Hospital Tabor
Tábor, , Czechia
Masaryk Hospital
Ústí nad Labem, , Czechia
Hospital Usti nad Orlici
Ústí nad Orlicí, , Czechia
Medical Department
Copenhagen NV, , Denmark
Medicinsk afdeling
Fredericia, , Denmark
Medicinsk afdeling F, Endokrinologisk
Hiller?d, , Denmark
Endokrinologisk afdeling
Hvidovre, , Denmark
Medical Department
Roskilde, , Denmark
Chu Sud
Amiens, , France
Centre Hospitalier
Beauvais, , France
Hopital Duchenne
Boulogne-sur-Mer, , France
Hopital Clemenceau
Caen, , France
Centre Hospitalier
Dunkirk, , France
Hopital Albert Michalon
La Tronche, , France
Hopital A.Mignot
Le Chesnay, , France
Hopital Maison Blanche
Reims, , France
Hopital Yves Le Foll
Saint-Brieuc, , France
Hopital Saint Quentin
Saint-Quentin, , France
Centre Hospitalier
Valenciennes, , France
Boehringer Ingelheim Investigational Site
Aschaffenburg, , Germany
Diabetes Klinik Bad Mergentheim
Bad Mergentheim, , Germany
Institut fur Klinische Forschung
Berlin, , Germany
Charite Campus Buch
Berlin, , Germany
KFH Dialysezentrum
Eberswalde, , Germany
Universitatsklinik Heidelberg
Heidelberg, , Germany
Boehringer Ingelheim Investigational Site
Karlsruhe, , Germany
Institut fur Klinische Forschung
Mainz, , Germany
Boehringer Ingelheim Investigational Site
Münster, , Germany
Boehringer Ingelheim Investigational Site
Neuwied, , Germany
Boehringer Ingelheim Investigational Site
Pirna, , Germany
Boehringer Ingelheim Investigational Site
Riesa, , Germany
Boehringer Ingelheim Investigational Site
Rosenheim, , Germany
Boehringer Ingelheim Investigational Site
Saarbrücken, , Germany
Boehringer Ingelheim Investigational Site
Saarlouis, , Germany
Boehringer Ingelheim Investigational Site
Sinsheim, , Germany
Boehringer Ingelheim Investigational Site
Speyer, , Germany
Internist
Würzburg, , Germany
Azienda Ospedaliera Policlinico S. Orsola Malpighi
Bologna, , Italy
Ospedali Riuniti di Livorno
Livorno, , Italy
Presidio Ospedaliero Campo di Marte
Lucca, , Italy
Universita degli Studi "Federico II"
Napoli, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
IRCCS Policlinico S.Matteo
Pavia, , Italy
Policlinico Monteluce
Perugia, , Italy
Azienda Ospedaliera S. Maria degli Angeli
Pordenone, , Italy
Ospedale "S. Maria delle Croci"
Ravenna, , Italy
Universita Tor Vergata
Roma, , Italy
Penang General Hospital
George Town, , Malaysia
Hospital Ipoh
Ipoh, Perak, , Malaysia
University Sains Malaysia
Kelantan, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Putrajaya
Kuala Selangor, , Malaysia
Centro Hospitalar de Coimbra
Coimbra, , Portugal
Hospital Distrital de Faro
Faro, , Portugal
Hospital Curry Cabral
Lisbon, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
Hospital de Santa Marta
Lisbon, , Portugal
Associac?o Protectora dos Diabeticos de Portugal
Lisbon, , Portugal
Hospital Pedro Hispano
Matosinhos Municipality, , Portugal
Hospital de S. Jo?o
Porto, , Portugal
Centro Hospitalar Vila Nova de Gaia
Vila Nova de Gaia, , Portugal
Medical Academy named Sechenova I.M.
Moscow, , Russia
Russian State Medical University
Moscow, , Russia
Russian State Medical University
Moscow, , Russia
National Endocrinology Research Center of Russia
Moscow, , Russia
Russian State Medical University
Moscow, , Russia
President's Medical Center
Moscow, , Russia
Russian Cardiology Research Center
Moscow, , Russia
Russian Academy for Advanced Medical Studies
Moscow, , Russia
Moscow President's Medical Center
Moscow, , Russia
Regional Clinical Scientific Research Institute
Moscow, , Russia
City Hospital of Saint Elizaveta
Saint Petersburg, , Russia
Military Medical Academy
Saint Petersburg, , Russia
NovaMed
Banská Bystrica, , Slovakia
Ministry Hospital of Internal Affairs
Bratislava, , Slovakia
Faculty Hospital
Bratislava, , Slovakia
Faculty Hospital of L. Derer
Bratislava, , Slovakia
Diabetologic and Internal Clinic
Lučenec, , Slovakia
Faculty Hospital
Nitra, , Slovakia
Hospital Nove Mesto
Nové Mesto, , Slovakia
Regional Hospital Nove Zamky
Nové Zámky, , Slovakia
MSP-DIAGNOSTIK, Ltd.
Trenčín, , Slovakia
Faculty Hospital Trnava
Trnava, , Slovakia
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Yonsei University Medical Center
Seoul, , South Korea
Hospital Torrecardenas
Almería, , Spain
Hospital Ntra. Sra de Sonsoles
Ávila, , Spain
Hospital Clinico y Provincial de Barcelona
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital de Basurto
Bilbao, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital de Cabuenes
Gijón, , Spain
Hospital Virgen del Rocio
Seville, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Changhua Christian Hospital
Changhua, , Taiwan
Chi Mei Medical Center
Dawan, , Taiwan
Buddhist Tzu Chi Hospital
Hualien City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Dnyepropyetrovsk Medical Academy
Dnyepropetrovsk, , Ukraine
Kharkiv Medical State University
Kharkiv, , Ukraine
Institute of Diabetic pathology problems
Kharkiv, , Ukraine
Institute of Cardiology
Kiev, , Ukraine
V.P. Komisarenko Institute of Endocrinology and Metabolism
Kiev, , Ukraine
Kyiv Clinical Hospital No. 1
Kyiv, , Ukraine
Zaporozhye Regional Clinical Hospital
Zaporizhzhya, , Ukraine
Countries
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Other Identifiers
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502.396
Identifier Type: -
Identifier Source: org_study_id