A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.

A Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Roty F.C. Tablets 10mg Versus Crestor 10mg F.C. Tablets in Patients With Hypercholesterolemia

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01982461

Enrollment

Registered

2013-11-13

Start date

2013-11-30

Completion date

Unknown

Last updated

2013-11-13

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

Conditions

Hypercholesterolemia

Brief summary

The objective of this trial is to assess the efficacy of reducing plasma low-density lipoprotein(LDL) cholesterol and safety in two different brand drugs, Roty F.C. Tablets 10mg and Crestor 10mg F.C. Tablets in hypercholesterolemia population.

Interventions

DRUGRosuvastatin

10mg,once daily

DRUGCrestor®

10mg,once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Male or female aged 20 to 85; * LDL - C between 130 mg/dL and 250 mg/dL; * TG \< 400 mg/dL; * Who without use of any statin within 2 week prior to the trial; * Informed consent given.

Exclusion criteria

* Known hypersensitivity or history of SAE with another HMG-CoA reductase inhibitor, in particular any history of myopathy; * Active liver disease/severe hepatic impairment(Child-Pugh C,ALT2×ULN); * Treatment with Cyclosporin or any disallowed drug; * Patients with unstable angina pectoris; * Pregnant, lactating women; * Patients who have severe medical condition(s) that in the view of the Investigator prohibits participation in the trial.

Design outcomes

Primary

Measure	Time frame
The primary efficacy variable will be defined as the percent mean change in LDL-C from baseline to 12 weeks.	baseline to week 12

Secondary

Measure	Time frame
The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1.	baseline to week 12

Countries

Taiwan

Contacts

Primary ContactLu-Hsin Lu, M.S.

flora@twtungda.com.tw886-2-26270255

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026