A prospective randomized control study of combination therapy with low-dose methimazole and a cholesterol absorption inhibitor as for the initial treatment of childhood-onset Graves disease

A prospective randomized control study of combination therapy with low-dose methimazole and a cholesterol absorption inhibitor as for the initial treatment of childhood-onset Graves disease - A prospective randomized control study of combination therapy with low-dose methimazole and a cholesterol absorption inhibitor as for the initial treatment of childhood-onset Graves disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014383

Enrollment

Registered

2014-06-27

Start date

2014-06-27

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

Graves disease

Interventions

methimazole methimazole and a cholesterol absorption inhibitor (colestimide)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with newly diagnosed Graves' disease 2) Serum FT4 value more than 5.0 ng/dl 3) Written informed consent from the patients' parents or legal guardians.

Exclusion criteria

Exclusion criteria: 1) Patients with thyrotoxic crisis 2) Patients who receive pharmacotherapy for diabetes, hepatic and renal disease 3) Medical history of Graves disease. Patients who have already used cholesterol absorption inhibitor. 4) Use of coumarin anticoagulants, digitalis, and bile acids preparations 5) Judged inappropriate for this study by the physicians.

Design outcomes

Primary

Measure	Time frame
The normalization rate of levels of free T4 and free T3 at the 4 weeks treatment.	—

Secondary

Measure	Time frame
Time to relief of hyperthyroid symptoms The normalization rate of levels of free T4 and free T3 at the 8, 12, and 24 weeks treatment. Change of levels of TRAb, Total cholesterol, CPK and 25 hydroxy vitamin D	—

Countries

Japan

Contacts

Public ContactKeisuke Nagasaki

ABC Tx Group Department of Pediatrics, Niigata University

nagasaki@med.niigata-u.ac.jp025-227-2222

Outcome results

None listed

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