A randomized, prospective, double-blind study to evaluate the effects on lipid profile of combined Ezetimibe and Simvastatin therapy as compared to Simvastatin alone in people with type 2 diabetes

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004525-99-IT

Enrollment

108

Registered

2005-06-27

Start date

2004-11-09

Completion date

Unknown

Last updated

2021-09-13

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

Conditions

Effects of Ezetimibe-simvastatin combined therapy in ameliorating the lipid profile and the overall cardiovascular and renal risk profile of patients with type 2 diabetes MedDRA version: 6.1 Level: PT Classification code 10049746

Interventions

Trade Name: ezetrol Product Name: NA Product Code: NA Pharmaceutical Form: Tablet INN or Proposed INN: Ezetimibe Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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:

Design outcomes

Primary

Measure	Time frame
Main Objective: ;Secondary Objective: ;Primary end point(s):	—

Countries

Italy

Outcome results

None listed

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