1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy
Launched by BOEHRINGER INGELHEIM · Sep 9, 2005
Trial Information
Current as of May 27, 2025
Completed
Keywords
ClinConnect Summary
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 sch...
Gender
ALL
Eligibility criteria
- 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
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Padova, , Italy
Valencia, , Spain
Dnyepropetrovsk, , Ukraine
Kiev, , Ukraine
Changhua, , Taiwan
Kuala Lumpur, , Malaysia
Lisboa, , Portugal
Bilbao, , Spain
Cordoba, , Spain
Brno, , Czech Republic
Hradec Kralove, , Czech Republic
Prague 10, , Czech Republic
Prague 2, , Czech Republic
Tabor, , Czech Republic
Usti Nad Labem, , Czech Republic
Usti Nad Orlici, , Czech Republic
Copenhagen Nv, , Denmark
Fredericia, , Denmark
Hiller?D, , Denmark
Hvidovre, , Denmark
Roskilde, , Denmark
Amiens, , France
Beauvais, , France
Boulogne Sur Mer Cedex, , France
Caen Cedex 5, , France
Dunkerque, , France
La Tronche, , France
Le Chesnay, , France
Reims, , France
Saint Brieuc Cedex 1, , France
Saint Quentin, , France
Valenciennes, , France
Aschaffenburg, , Germany
Bad Mergentheim, , Germany
Berlin, , Germany
Berlin, , Germany
Eberswalde, , Germany
Heidelberg, , Germany
Karlsruhe, , Germany
Mainz, , Germany
Munster, , Germany
Neuwied, , Germany
Pirna, , Germany
Riesa, , Germany
Rosenheim, , Germany
Saarbrucken, , Germany
Saarlouis, , Germany
Sinsheim, , Germany
Speyer, , Germany
Wurzburg, , Germany
Bologna, , Italy
Livorno, , Italy
Lucca, , Italy
Napoli, , Italy
Pavia, , Italy
Perugia, , Italy
Pordenone, , Italy
Ravenna, , Italy
Roma, , Italy
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Ipoh, Perak, , Malaysia
Kelantan, , Malaysia
Kuala Lumpur, , Malaysia
Penang, , Malaysia
Selangor, , Malaysia
Coimbra, , Portugal
Faro, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Lisbon, , Portugal
Matosinhos, , Portugal
Porto, , Portugal
Vila Nova De Gaia, , Portugal
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
St. Petersburg, , Russian Federation
St. Petersburg, , Russian Federation
Banska Bystrica, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Lucenec, , Slovakia
Nitra, , Slovakia
Nove Mesto, , Slovakia
Nove Zamky, , Slovakia
Trencin, , Slovakia
Trnava, , Slovakia
Almeria, , Spain
Avila, , Spain
Barcelona, , Spain
Barcelona, , Spain
Gijon, , Spain
Sevilla, , Spain
Hualien City, , Taiwan
Tainan, , Taiwan
Taipei, , Taiwan
Taiwan, , Taiwan
Kharkov, , Ukraine
Kharkov, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Zaporozhye, , Ukraine
Patients applied
Trial Officials
Boehringer Ingelheim Study Coordinator
Study Chair
B.I. Pharma GmbH & Co. KG
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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