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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005021-60-DE
Enrollment
Unknown
Registered
2006-12-05
Start date
2007-04-16
Completion date
Unknown
Last updated
2013-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of hypertension and endothelial dysfunction with Telmisartan in patients with haemodialysis due to chronic renal failure.

Interventions

Trade Name: Kinzalmono 80 mg Tabletten Product Name: Telmisartan 80 mg Pharmaceutical Form: Capsule* INN or Proposed INN: Telmisartan CAS Number: 144701-48-4 Current Sponsor code: BIBR 277 SE Concen

Sponsors

Prof. Dr. R. Kreutz Leiter der Abteilung Klinische Pharmakologie der Charite Berlin
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026