Monozentrische, randomisierte, einfach verblindete, Placebo kontrollierte Studie im Cross over Design zur Untersuchung der Wirkung von Telmisartan (Kinzalmono 80 mg) auf Blutdruck und Endothelfunktion bei Patienten unter Hämodialysebehandlung. - DIATEL Studie
- Conditions
- Treatment of hypertension and endothelial dysfunction with Telmisartan in patients with haemodialysis due to chronic renal failure.
- Registration Number
- EUCTR2005-005021-60-DE
- Lead Sponsor
- Prof. Dr. R. Kreutz Leiter der Abteilung Klinische Pharmakologie der Charite Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
patients (male or female) with haemodialysis due to chronic renal failure age over 18 years and below 80 years which suffer from hypertension.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
patients without antihypertensive treatment and blood pressure below 120 mm Hg systolic
patients with standardized antihypertensive treatment and blood pressure over 170 mm Hg
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy and safety of Telmisartan in patients which are haemodialysed due to chronic renal failure;Secondary Objective: Pharmacokinetics of Telmisartan;Primary end point(s): efficacy and safety of Telmisartan in patients with haemodialysis
- Secondary Outcome Measures
Name Time Method