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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Pin Siang Medical Biotechnology Co., Ltd..
Recruitment status was:  Recruiting
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 Name: Rosuvastatin

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982461

Locations
Taiwan
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
  More Information

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 Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on December 02, 2016