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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 6, 2013
CompletedFirst Posted
Study publicly available on registry
November 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedNovember 13, 2013
November 1, 2013
2 months
November 6, 2013
November 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1.
baseline to week 12
Study Arms (2)
Rosuvastatin
EXPERIMENTALOne Rosuvastatin tablet 10mg taken once daily.
Crestor®
ACTIVE COMPARATOROne Crestor® tablet 10mg taken once daily.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tri-Service General Hospital
Taipei, 11490, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi-Jen Hung, M.D.
Tri-Service General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2013
First Posted
November 13, 2013
Study Start
November 1, 2013
Primary Completion
January 1, 2014
Last Updated
November 13, 2013
Record last verified: 2013-11