Investigation on the effectiveness and safety of lipid-lowering treatments in patients with familial hypercholesterolemia (FAME: Familial Hypercholesterolemia Expert Forum Trial)

Investigation on the effectiveness and safety of lipid-lowering treatments in patients with familial hypercholesterolemia (FAME: Familial Hypercholesterolemia Expert Forum Trial) - Familial Hypercholesterolemia Expert Forum Trial (FAME)

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000003211

Enrollment

1000

Registered

2010-02-19

Start date

2009-09-15

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

familial hypercholesterolemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria for patients with familial hypercholesterolemia: All of the following 4 criteria must be met. 1) Patients who are diagnosed as heterozygous familial hypercholesterolemia (FH) assessed by the clinical diagnostic criteria settled by the Research Committee of the Japanese Ministry of Health, Labour and Welfare. Patients with scores > 8 are definite FH and those with scores with 6 or 7 are probable FH. 2) Patients should have their serum LDL cholesterol level >100 mg/dl. If patients have been taking ezetimibe, the pre-treatment level of LDL cholesterol should be >100 mg/dl. 3) Study subjects should be outpatients of hospitals which participate in this study. 4) Patients who gave a written informed consent. If patients are under 16 years old, a written informed consent should be taken from their legally authorized representatives. If patients are 16 to 19 years old, a written informed consent should be taken from both patients and their legally authorized representatives.

Exclusion criteria

Exclusion criteria: 1) Patients whose serum triglyceride level is over 400 mg/dl at the time of registration should be excluded. 2) Patients who are suffering from severe liver dysfunction (acute phase and decompensated cirrhosis) 3) Patients with dyslipidemia who are suffering from the following diseases (1) hypothyroidism (2) pancreatitis 4) Patients with uncontrolled diabetes mellitus, whose HbA1c level is over 9%. 5) Patients who are pregnant, suckling or likely to be pregnant. 6) Patients who are judged by the doctor to be improper to be enrolled in this study.

Design outcomes

Primary

Measure	Time frame
Effectiveness (lowering effects on serum lipids and intima-media thickness of the carotid arteries) and safety of lipid-lowering drugs	—

Countries

Japan

Contacts

Public ContactDaisaku Masuda

Osaka University Graduate School of Medicine Department of Cardiovascular Medicine

masuda@cardiology.med.osaka-u.ac.jp06-6879-3633

Outcome results