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

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ClinicalTrials.gov Identifier: NCT01982461
Recruitment Status : Unknown
Verified November 2013 by Pin Siang Medical Biotechnology Co., Ltd..
Recruitment status was:  Recruiting
First Posted : November 13, 2013
Last Update Posted : November 13, 2013
Sponsor:
Information provided by (Responsible Party):

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
Hypercholesterolemia Drug: Rosuvastatin Drug: Crestor®

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2013
Estimated Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Rosuvastatin
One Rosuvastatin tablet 10mg taken once daily.
Drug: Rosuvastatin
10mg,once daily
Other Name: Roty
Active Comparator: Crestor®
One Crestor® tablet 10mg taken once daily.
Drug: Crestor®
10mg,once daily
Other Name: 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. [ Time Frame: 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. [ Time Frame: baseline to week 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982461


Contacts
Contact: Lu-Hsin Lu, M.S. 886-2-26270255 ext 206 flora@twtungda.com.tw

Locations
Taiwan
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 11490
Contact    886-2-87923311 ext 10552    tsghirb@ndmctsgh.edu.tw   
Sponsors and Collaborators
Pin Siang Medical Biotechnology Co., Ltd.
Investigators
Principal Investigator: Yi-Jen Hung, M.D. Tri-Service General Hospital
More Information

Responsible Party: Pin Siang Medical Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01982461     History of Changes
Other Study ID Numbers: PSMB102ROS10-01
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors