A Phase IV, Multi-centre, Randomised, Double-Blind Study to Evaluate the Efficacy and Safety of NK- 104 versus Atorvastatin in Chinese Patients with Hypercholesterolaemia

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221598

Enrollment

480

Registered

2011-09-28

Start date

2011-09-28

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

Hypercholesterolaemia

Interventions

investigational material(s) Generic name etc : NK-104 INN of investigational material : Therapeutic category code : 218 Agents for hyperlipidemias Dosage and Administration for Investigational materi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed with hypercholesterolaemia

Exclusion criteria

Exclusion criteria: 1.Any conditions which may cause secondary dyslipidemia 2.Uncontrolled diabetes mellitus 3.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug

Design outcomes

Primary

Measure	Time frame
LDL-C Percent change from baseline LDL-C at Week 12	—

Secondary

Measure	Time frame
LDL-C, TC, HDL-C, TG, non-HDL, Apo-B and Apo-A1 Percent change from baseline for LDL-C, TC, HDL-C, TG, non-HDL, Apo-B and Apo-A1 over time	—

Outcome results

None listed

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