Trial | NCT01982461  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    rosuvastatin ...

  • Study Participants

    40
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 Started
Nov 30
2013
Primary Completion
Jan 31
2014
Anticipated
Last Update
Nov 13
2013
Estimate

Drug Rosuvastatin

10mg,once daily

  • Other names: Roty

Drug Crestor®

10mg,once daily

  • Other names: Rosuvastatin

Rosuvastatin Experimental

One Rosuvastatin tablet 10mg taken once daily.

Crestor® Active Comparator

One Crestor® tablet 10mg taken once daily.

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.
No Results Posted