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

Sponsor
Pin Siang Medical Biotechnology Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01982461
Collaborator
(none)
40
Enrollment
1
Location
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Nov 1, 2013
Anticipated Primary Completion Date :
Jan 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rosuvastatin

One Rosuvastatin tablet 10mg taken once daily.

Drug: Rosuvastatin
10mg,once daily
Other Names:
  • Roty

    		•
    Active Comparator: Crestor®

    One Crestor® tablet 10mg taken once daily.

    Drug: Crestor®
    10mg,once daily
    Other Names:
  • Rosuvastatin

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1. [baseline to week 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tri-Service General Hospital Taipei Taiwan 11490

    Sponsors and Collaborators

    • Pin Siang Medical Biotechnology Co., Ltd.

    Investigators

    • Principal Investigator: Yi-Jen Hung, M.D., Tri-Service General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pin Siang Medical Biotechnology Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01982461
    Other Study ID Numbers:
    • PSMB102ROS10-01
    First Posted:
    Nov 13, 2013
    Last Update Posted:
    Nov 13, 2013
    Last Verified:
    Nov 1, 2013
    Additional relevant MeSH terms:
    Hypercholesterolemia
    Rosuvastatin Calcium

    Study Results

    No Results Posted as of Nov 13, 2013