Clinical research on concurrent therapy of Ezetimibe and Statin

Clinical research on concurrent therapy of Ezetimibe and Statin - Absorption control Concurrent Therapy study(ACT study)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003168

Enrollment

200

Registered

2010-02-12

Start date

2010-02-01

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

Coronary artery disease or diabetic

Interventions

Coronary artery disease patients who have more than 100mg/dL of LDL-C in spite of taking statin will be additionally administered ezetimib 10mg/day for 6~9 months.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Coronary artery disease patients who have more than 100mg/dL of LDL-C in spite of taking statin for at least 3 month. Or, diabetic patients who have more than 120mg/dL of LDL-C in spite of taking statin for at least 3 month.

Exclusion criteria

Exclusion criteria: (1)Patient that there is previous history of hypersensitivity in experimental drug or Statin (2)TG 400mg/dL or more (When the measurement of LDL-C is only a calculation method) (3)Patients with hepatic dysfunction (ALT>3 x upper limit of normal range) (4)Patients with renal dysfunction (Serum creatinine >2 x upper limit of normal range) (5)Patient of 9% or more in HbA1c (6)Patient of 1% or more in change of HbA1c (7)Patients with secondary hyperlipidemia or medicinal hyperlipemia (8)Patients with a history of CABG operation or stroke within recent 3 months (9)Pregnant or possibly pregnant women (10)Patients who are judged to be inappropriate as a subject by a doctor

Design outcomes

Primary

Measure	Time frame
Change of LDL-C	—

Secondary

Measure	Time frame
1)Accomplishment rate of less than LDL-C100mg/dL and accomplishment rate of less than LDL-C70mg/dL in patient with coronary artery disease. Or, the accomplishment rate of less than LDL-C value 120mg/dL in the diabetic. 2)Decreasing of hs-CRP. 3)Accomplishment rate of less than LDL-C70mg and less than hs-CRP0.2mg/dL in coronary artery disease person. 4)Change of HDL-C, LDL-C/HDL-C, nonHDL-C. 5)Electrocardiogram(improvement level of ST-T, ventricular rate, left ventricular hypertrophy (SV1+RV5)). 6)Change of kidney function(s-Cr, eGFR).	—

Measure

Time frame

1)Accomplishment rate of less than LDL-C100mg/dL and accomplishment rate of less than LDL-C70mg/dL in patient with coronary artery disease. Or, the accomplishment rate of less than LDL-C value 120mg/dL in the diabetic. 2)Decreasing of hs-CRP. 3)Accomplishment rate of less than LDL-C70mg and less than hs-CRP0.2mg/dL in coronary artery disease person. 4)Change of HDL-C, LDL-C/HDL-C, nonHDL-C. 5)Electrocardiogram(improvement level of ST-T, ventricular rate, left ventricular hypertrophy (SV1+RV5)). 6)Change of kidney function(s-Cr, eGFR).

—

Countries

Japan

Contacts

Public ContactTAKAFUMI NAKAGAWA

Tokushima Red Cross Hospital Division of cardiology

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026