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	Intervention	Phase
Diabetic Nephropathies Hypertension	Drug: Telmisartan  Drug: Valsartan	Phase IV

Further Study Details: 

Primary Outcomes: Change from baseline (Visit 6) in 24 hour proteinuria, after one year of treatment (study end) with telmisartan 80 mg versus valsartan 160 mg.
Secondary Outcomes: Change from baseline in 24 h albuminuria, creatinine clearance, estimated GFR, serum creatinine, 24 h sodium excretion, ADMA, 8-iso-prostaglandin F2a, hs CRP Doubling of serum creatinine Composite of cardiovascular morbidity and mortality
Expected Total Enrollment:  890

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 weeks 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 perid 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 (24h 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 (24h 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.

Ages Eligible for Study:  30 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

1. Type 2 diabetes mellitus.
2. Aged 30-70 years of age.

3. Hypertension at screening defined as

   1. an average cuff systolic blood pressure >130 mmHg and/or diastolic blood pressure >80 mmHg in untreated patients, or
   2. 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 µmol/l (3.0 mg/dl)

Czech Republic
      Boehringer Ingelheim Investigational Site, Prague,  Czech Republic
      Boehringer Ingelheim Investigational Site, Tabor,  Czech Republic
      Boehringer Ingelheim Investigational Site, Prague,  Czech Republic
      Boehringer Ingelheim Investigational Site, HRADEC KRALOVE,  Czech Republic
      Boehringer Ingelheim Investigational Site, Brno,  Czech Republic
      Boehringer Ingelheim Investigational Site, Usti nad Labem,  Czech Republic
      Boehringer Ingelheim Investigational Site, Usti nad Orlici,  Czech Republic
Denmark
      Boehringer Investigational Site, Roskilde,  Denmark
      Boehringer Investigational Site, Hvidovre,  Denmark
      Boehringer Investigational Site, Hillerød,  Denmark
      Boehringer Investigational Site, Fredericia,  Denmark
France
      Boehringer Ingelheim Investigational Site, Caen,  France
      Boehringer Ingelheim Investigational Site, Grenoble,  France
      Boehringer Ingelheim Investigational Site, Saint-Brieuc,  France
      Boehringer Ingelheim Investigational Site, Reims,  France
      Boehringer Ingelheim Investigational Site, Valenciennes,  France
      Boehringer Ingelheim Investigational Site, Amiens,  France
      Boehringer Ingelheim Investigational Site, Boulogne-sur-Mer,  France
      Boehringer Ingelheim Investigational Site, Le Chesnay,  France
      Boehringer Ingelheim Investigational Site, Beauvais,  France
      Boehringer Ingelheim Investigational Site, Saint-Quentin,  France
Germany
      Boehringer Ingelheim Investigational Site, Aschaffenburg,  Germany
      Boehringer Ingelheim Investigational Site, Karlsruhe,  Germany
      Boehringer Ingelheim Investigational Site, Pirna,  Germany
      Boehringer Ingelheim Investigational Site, Riesa,  Germany
      Boehringer Ingelheim Investigational Site, Saarlouis,  Germany
      Boehringer Ingelheim Investigational Site, Sinsheim,  Germany
      Boehringer Ingelheim Investigational Site, Heidelberg,  Germany
      Boehringer Ingelheim Investigational Site, Saarbrücken,  Germany
      Boehringer Ingelheim Investigational Site, Mainz,  Germany
      Boehringer Ingelheim Investigational Site, Dresden,  Germany
      Boehringer Ingelheim Investigational Site, Speyer,  Germany
      Boehringer Ingelheim Investigational Site, Eberswalde,  Germany
      Boehringer Ingelheim Investigational Site, Bad Mergentheim,  Germany
      Boehringer Ingelheim Investigational Site, Neuwied,  Germany
Italy
      Boehringer Ingelheim Investigational Site, Lucca,  Italy
      Boehringer Ingelheim Investigational Site, Livorno,  Italy
      Boehringer Ingelheim Investigational Site, Perugia,  Italy
      Boehringer Ingelheim Investigational Site, Pavia,  Italy
      Boehringer Ingelheim Investigational Site, Ravenna,  Italy
      Boehringer Ingelheim Investigational Site, Padova,  Italy
      Boehringer Ingelheim Investigational Site, Roma,  Italy
      Boehringer Ingelheim Investigational Site, Pordenone,  Italy
      Boehringer Ingelheim Investigational Site, Torino,  Italy
      Boehringer Ingelheim Investigational Site, Napoli,  Italy
      Boehringer Ingelheim Investigational Site, Bologna,  Italy
Korea, Republic of
      Boehringer Ingelheim Investigational Site, Seoul,  Korea, Republic of
      Boehringer Ingelheim Investigational Site, Daegu,  Korea, Republic of
Malaysia
      Boehringer Ingelheim Investigational Site, Kuala Lumpur,  Malaysia
      Boehringer Ingelheim Investigational Site, Kuala Lumpur,  Malaysia
      Boehringer Ingelheim Investigational Site, Penang,  Malaysia
      Boehringer Ingelheim Investigational Site, Kelantan,  Malaysia
      Boehringer Ingelheim Investigational Site, Selangor,  Malaysia
      Boehringer Ingelheim Investigational Site, Ipoh, Perak,  Malaysia
Portugal
      Boehringer Ingelheim Investigational Site, MATOSINHOS,  Portugal
      Boehringer Ingelheim Investigational Site, Porto,  Portugal
      Boehringer Ingelheim Investigational Site, Porto,  Portugal
      Boehringer Ingelheim Investigational Site, Lisboa,  Portugal
      Boehringer Ingelheim Investigational Site, Lisboa,  Portugal
      Boehringer Ingelheim Investigational Site, Lisboa,  Portugal
      Boehringer Ingelheim Investigational Site, Lisboa,  Portugal
      Boehringer Ingelheim Investigational Site, Coimbra,  Portugal
      Boehringer Ingelheim Investigational Site, Faro,  Portugal
      Boehringer Ingelheim Investigational Site, Carnaxide,  Portugal
      Boehringer Ingelheim Investigational Site, Coimbra,  Portugal
      Boehringer Ingelheim Investigational Site, Vila Nova de Gaia,  Portugal
      Boehringer Ingelheim Investigational Site, Lisboa,  Portugal
      Boehringer Ingelheim Investigational Site, Lisbon,  Portugal
Russian Federation
      Boehringer Ingelheim Investigational Site, Moscow,  Russian Federation
      Boehringer Ingelheim Investigational Site, Moscow,  Russian Federation
      Boehringer Ingelheim Investigational Site, Moscow,  Russian Federation
      Boehringer Ingelheim Investigational Site, Moscow,  Russian Federation
      Boehringer Ingelheim Investigational Site, Moscow,  Russian Federation
      Boehringer Ingelheim Investigational Site, Moscow,  Russian Federation
      Boehringer Ingelheim Investigational Site, Moscow,  Russian Federation
      Boehringer Ingelheim Investigational Site, Moscow,  Russian Federation
      Boehringer Ingelheim Investigational Site, Moscow,  Russian Federation
      Boehringer Ingelheim Investigational Site, Moscow,  Russian Federation
      Boehringer Ingelheim Investigational Site, Moscow,  Russian Federation
      Boehringer Ingelheim Investigational Site, St Petersburg,  Russian Federation
      Boehringer Ingelheim Investigational Site, St Petersburg,  Russian Federation
Slovakia
      Boehringer Ingelheim Investigational Site, Bratislava,  Slovakia
      Boehringer Ingelheim Investigational Site, Bratislava,  Slovakia
      Boehringer Ingelheim Investigational Site, Nitra,  Slovakia
      Boehringer Ingelheim Investigational Site, Bratislava,  Slovakia
      Boehringer Ingelheim Investigational Site, Bratislava,  Slovakia
      Boehringer Ingelheim Investigational Site, Nove Zamky,  Slovakia
      Boehringer Ingelheim Investigational Site, Lucenec,  Slovakia
      Boehringer Ingelheim Investigational Site, Trencin,  Slovakia
      Boehringer Ingelheim Investigational Site, Trnava,  Slovakia
      Boehringer Ingelheim Investigational Site, Banska Bystrica,  Slovakia
      Boehringer Ingelheim Investigational Site, Nove Mesto,  Slovakia
Spain
      Boehringer Ingelheim Investigational Site, Barcelona,  Spain
      Boehringer Ingelheim Investigational Site, CÓRDOBA,  Spain
      Boehringer Ingelheim Investigational Site, Almería,  Spain
      Boehringer Ingelheim Investigational Site, Sevilla,  Spain
      Boehringer Ingelheim Investigational Site, Bilbao,  Spain
      Boehringer Ingelheim Investigational Site, Gijon,  Spain
      Boehringer Ingelheim Investigational Site, Valencia,  Spain
      Boehringer Ingelheim Investigational Site, Avila,  Spain
Taiwan
      Boehringer Ingelheim Investigational Site, Tainan,  Taiwan
      Boehringer Ingelheim Investigational Site, Taipei,  Taiwan
      Boehringer Ingelheim Investigational Site, Taiwan,  Taiwan
      Boehringer Ingelheim Investigational Site, Changhua,  Taiwan
      Boehringer Ingelheim Investigational Site, Hualien City,  Taiwan
Ukraine
      Boehringer Ingelheim Investigational Site, Kharkov,  Ukraine
      Boehringer Ingelheim Investigational Site, Kharkov,  Ukraine
      Boehringer Ingelheim Investigational Site, Dnyepropetrovsk,  Ukraine
      Boehringer Ingelheim Investigational Site, Zaporozhye,  Ukraine
      Boehringer Ingelheim Investigational Site, Kiev,  Ukraine
      Boehringer Ingelheim Investigational Site, Kyiv,  Ukraine
      Boehringer Ingelheim Investigational Site, Kiev,  Ukraine

Study chairs or principal investigators

Sabine Quispe Bravo, Dr.,  Study Chair,  B.I. Pharma GmbH & Co. KG   

Study ID Numbers:  502.396
Last Updated:  September 9, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00153023
Health Authority: Germany: BfArM; Czech Republic: SUKL (state institute for drug control); Russia: Ministry of Health Care of Russian Federation (MoH of Russia); Slovakia: SUKL (state institute for drug control); Ukraine: Ministry of Health Crae of Ukraine (MoH of Ukraine); Denmark: Danish Medicines Agency; Spain: Ministry of Health; France: AFSSAPS; Italy: Universita degli Studi di Napoli "Federico II" - Comitato Etico; Malaysia: Ministry of Health, National Pharmaceutical Control Bureau (NPCB), 6 main ECs; Portugal: INFARMED; Taiwan: DOH(Department of Health); Korea: KOREA Food and Drug Administration (KFDA); South Africa: MCC (Medicines Control Council)
ClinicalTrials.gov processed this record on 2005-09-13