The Efficacy and Safety of Atorva® 20mg Versus Lipitor® 20mg

Hypercholesterolemia Clinical Trial

Official title:

A Multi-center, Randomized, Open-labeled Clinical Trial to Evaluate Efficacy and Safety of Atorva® 20mg Versus Lipitor® 20mg in Korean Patients With Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624207
• Other study ID #: ROYAL
• Secondary ID: H-1002-038-309
• Status: Completed
• Phase: Phase 4
• First received: June 18, 2012
• Last updated: December 15, 2013
• Start date: March 2010
• Est. completion date: April 2011

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The generic formulation of atorvastatin (Atorva®) 20mg was not inferior to the branded formulation of atorvastatin (Lipitor®) 20mg in this 8-week treatment of hyperlipidemic Korean patients. In PP analysis, the LDL cholesterol goal achievement rate was significantly higher in Atorva group. Both treatments were well tolerated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: April 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

Inclusion Criteria:

• Eligible patients were men or women aged between 20 and 79 years who have not achieved LDL cholesterol goals using the National Cholesterol Education Program Adult Treatment Panel ? (NCEP-ATP ?) guideline, with the treatment goal of LDL cholesterol being <100 mg/dL for patients with coronary artery disease (CAD) or CAD-equivalent disease, <130 mg/dL for patients with multiple risk factors (10-year coronary heart disease [CHD] risk =20%), and <160 mg/dL for patients with 0 to 1 risk factors.

Exclusion Criteria:

• Exclusion criteria were as follows: currently taking any kind of anti-hyperlipidemic drug (within 4 weeks before enrollment); hypersensitivity or intolerance to atorvastatin or other HMG-CoA reductase inhibitor; newly diagnosed (within 3 months before enrollment) or uncontrolled diabetes (hemoglobin A1C >9%); uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg); hepatic dysfunction (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels =2 times the upper limit of normal [ULN]); an unexplained serum creatinine kinase (CK) elevation >2 times the ULN, chronic renal failure (a serum creatinine concentration >2.5 mg/dL); in patients who experienced operation at the time of screening, the patients must have a result of lipid profiles within 24 hours or after 6 weeks; a history of malignancy or cervical dysplasia; pregnant or breastfeeding women; women of childbearing potential had to be using adequate methods of contraception; a history of drug abuse or alcoholism; participation in other studies 4 weeks before enrollment. Patients could also be excluded if their participation was considered inappropriate by the study physician.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• generic formulation of atorvastatin (Atorva®)
Treatment with generic formulation of atorvastatin (Atorva®) once daily, for 8 weeks
• branded formulation of atorvastatin (Lipitor®)
Treatment with branded formulation of atorvastatin (Lipitor®)once daily, for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Yuhan corp., Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% change of LDL cholesterol	The difference in percent change of serum LDL cholesterol concentration between genericAtorva and Lipitor branded group	After 8 weeks of treatment	No
Secondary	% change of other lipid paramenters(total cholesterol, high-density lipoprotein [HDL] cholesterol, triglyceride [TG], apolipoprotein B [ApoB] and apolipoprotein A1 [ApoA1])		After 8 weeks of treatment	No
Secondary	% change of lipoprotein and apolipoprotein ratios (ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio)		After 8 weeks of treatment	No
Secondary	Change of highly sensitive C-reactive protein (hsCRP)		After 8 weeks of treatment	No
Secondary	LDL cholesterol goal achievement rate	LDL cholesterol goal achievement rate according to NECP-ATP III guideline	After 8 weeks of treatment	No