Influence of the angiotensin receptor blocker Telmisartan on the red blood cell function and the microcirculatory perfusion (ITEM) - ITEM

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002765-12-DE

Enrollment

Registered

2007-07-06

Start date

2007-11-05

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

arterial hypertension diabetes mellitus type 2 MedDRA version: 9.1 Level: LLT Classification code 10020775 Term: Hypertension arterial MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

Interventions

Trade Name: Kinzalmono 80 mg Product Name: Telmisartan 80 mg Product Code: BAY68-9291 Pharmaceutical Form: Tablet INN or Proposed INN: TELMISARTAN CAS Number: 144701484 Current Sponsor code: AIX-MK-01

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Men older than 18 years Diabetes mellitus type 2 defined according to the criteria of the American Diabetes Association Arterial hypertension defined according to the criteria of the Joint National Committees (JNC 7) Given informed consent 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: Severe heart failure Severe aortic valve stenosis or hypertrophic obstructive cardiomyopathy Relevant cardiac arrhythmias Acute myocardial infarction within the last 4 weeks Renal failure Bilateral renal artery stenosis Liver diseases Primary hyperaldosteronism Orthostatic hypotension (systolic blood pressure < 100 mmHg) Hypokalemia, hyponatremia, hypercalcemia, symptomatic hyperuricemia Hyponatriämie, Hyperkalziämie und symptomatische Hyerurikämie Inflammatory disease Malignant disease Previous intolerance to AT1 receptor antagonists and/or sulfonamides Current therapy with insulin sensitizer Current therapy with digoxin known abuse of alcohol or drugs

Design outcomes

Primary

Measure	Time frame
Main Objective: The regulation intake of telmisartan results in an increase of red blood cell deformability in patients with arterial hypertension and diabetes mellitus.;Secondary Objective: The regulation intake of telmisartan results in an increase of the microcirculatory perfusion in patients with arterial hypertension and diabetes mellitus.;Primary end point(s): Increase in red blood cell deformability	—

Measure

Time frame

Main Objective: The regulation intake of telmisartan results in an increase of red blood cell deformability in patients with arterial hypertension and diabetes mellitus.;Secondary Objective: The regulation intake of telmisartan results in an increase of the microcirculatory perfusion in patients with arterial hypertension and diabetes mellitus.;Primary end point(s): Increase in red blood cell deformability

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Countries

Germany

Outcome results

None listed

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