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

November 6, 2013 updated by: Pin Siang Medical Biotechnology Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11490
        • Recruiting
        • Tri-Service General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pin Siang Medical Biotechnology Co., Ltd.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

November 6, 2013

First Submitted That Met QC Criteria

November 6, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 6, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSMB102ROS10-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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