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

This study is currently recruiting participants.
Verified November 2013 by Pin Siang Medical Biotechnology Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Pin Siang Medical Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01982461
First received: November 6, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

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 Intervention
Hypercholesterolemia
Drug: Rosuvastatin
Drug: Crestor®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pin Siang Medical Biotechnology Co., Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1. [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • Rosuvastatin
  • Crestor®

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Pin Siang Medical Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01982461     History of Changes
Other Study ID Numbers: PSMB102ROS10-01
Study First Received: November 6, 2013
Last Updated: November 6, 2013
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on April 17, 2014