Efficacy and tolerability of Ezetimibe in cardiac transplant recipients taking Cyclosporin

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005565-18-GB

Enrollment

Registered

2011-08-22

Start date

2007-04-02

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Hyperlipidaemia in patients folowing cardiac transplantation MedDRA version: 14.0 Level: PT Classification code 10062060 Term: Hyperlipidaemia System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Ezetrol Product Name: Ezetimibe Pharmaceutical Form: Tablet Concentration unit: mg/g milligram(s)/gram Concentration type: e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Heart transplant recipients at least 3 months post transplant and currently taking cyclosporin, will be included whether they are taking statin therapy or not, regardless of their fasting lipid profile. 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: Exclusion criteria are: 1. Derangement of liver function tests or creatinine kinase (CK) levels (defined as AST/ALT or CK > 2 x upper limit of normal) 2. Concurrent malignancy 3. Lack of informed consent 4. Previous intolerance or allergy to Ezetimibe

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The primary endpoints are % change (from baseline) in concentrations of total and LDL cholesterol with Ezetimibe and placebo at 6 month follow-up; Main Objective: To assess the efficacy of ezetimibe at lowering Total Cholesterol (TC) and Low Density Lipoproteins (LDL) in patients after heart transplant whilst taking cyclosporin. The primary endpoints are : % change in total cholesterol (TC) and LDL (low density lipoproteins) from baseline ; Secondary Objective: To assess the safety of ezetimibe in patients after heart tranplant whilst taking cyclosporin. Secondary endpoints are: The number of patients who complained of adverse events, withdrew due to adverse events or had clinically relevant laboratory findings (two consecutive draws with a 3 x upper limit of normal increase in ALT/AST, CK > 5x upper limit of normal with symptoms, or CK > 10 x upper limit of normal with or without symptoms	—

Measure

Time frame

Primary end point(s): The primary endpoints are % change (from baseline) in concentrations of total and LDL cholesterol with Ezetimibe and placebo at 6 month follow-up; Main Objective: To assess the efficacy of ezetimibe at lowering Total Cholesterol (TC) and Low Density Lipoproteins (LDL) in patients after heart transplant whilst taking cyclosporin. The primary endpoints are : % change in total cholesterol (TC) and LDL (low density lipoproteins) from baseline ; Secondary Objective: To assess the safety of ezetimibe in patients after heart tranplant whilst taking cyclosporin. Secondary endpoints are: The number of patients who complained of adverse events, withdrew due to adverse events or had clinically relevant laboratory findings (two consecutive draws with a 3 x upper limit of normal increase in ALT/AST, CK > 5x upper limit of normal with symptoms, or CK > 10 x upper limit of normal with or without symptoms

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Countries

United Kingdom

Outcome results

None listed

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