Study on the effectiveness of a treatment with statine in reducing the morbility and cardiovascular mortality in patients with moderate-strict renal insufficiency. - ND

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005155-18-IT

Enrollment

350

Registered

2006-01-25

Start date

2004-02-24

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

patients with moderate-strict renal insufficiency MedDRA version: 6.1 Level: PT Classification code 10038474

Interventions

Trade Name: TORVAST 10 10 CPR 10 MG Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Atorvastatin CAS Number: 134523-03-8 Concentration unit: mg milligram(s) Concentration type: equal Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients of age 18-80 years, with moderated light renal insufficiency, identified from a VFG calculated with formula of Cockcoft and Gault between the 60 and 20 ml/min. 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 for which the cardiovascular risk is much elevated 40 . Patients already in treatment with statine.

Design outcomes

Primary

Measure	Time frame
Main Objective: To verify in a population of patients with moderate-strict IR that an aggressive treatment of cholesterolemia target the levels of cholesterol LDL 100 mg/dL meaningfully reduces the entity of a end point composite, constituted from mortality and cardiovascular morbility.;Secondary Objective: To verify in a population of patients with moderate-strict IR that an aggressive treatment of cholesterolemia target the levels of cholesterol LDL 100 mg/dL meaningfully reduces the entity of a end point composite, constituted from mortality and cardiovascular morbility.;Primary end point(s): A composite of serious cardiovascular events infarct, ictus, intestinal infarct, thrombosis renal arteries and cardiovascular mortality.	—

Measure

Time frame

Main Objective: To verify in a population of patients with moderate-strict IR that an aggressive treatment of cholesterolemia target the levels of cholesterol LDL 100 mg/dL meaningfully reduces the entity of a end point composite, constituted from mortality and cardiovascular morbility.;Secondary Objective: To verify in a population of patients with moderate-strict IR that an aggressive treatment of cholesterolemia target the levels of cholesterol LDL 100 mg/dL meaningfully reduces the entity of a end point composite, constituted from mortality and cardiovascular morbility.;Primary end point(s): A composite of serious cardiovascular events infarct, ictus, intestinal infarct, thrombosis renal arteries and cardiovascular mortality.

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Countries

Italy

Outcome results

None listed

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