Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients

Hyperlipidemia Clinical Trial

Official title:

A Double-blind, Double Dummy, Phase IV, Randomized, Multicenter, Parallel Group, Placebo Controlled Trial to Evaluate the Effect of Rosuvastatin on Triglycerides Levels in Mexican Hypertriglyceridemic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473655
• Other study ID #: DM-CRESTOR-0002
• Status: Completed
• Phase: Phase 4
• First received: May 14, 2007
• Last updated: November 30, 2010
• Start date: January 2007
• Est. completion date: February 2009

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of HealthMexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this trial is to determine if the treatment with rosuvastatin 10 and 20mg/day during 8 weeks in hypertriglyceridemic patients will reduce their triglyceride levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years, both genders, without any previous treatment with statins or other lipid lowering drugs for at least 6 months

• With elevated triglycerides above 200 and below 800mg/dl and willing to follow all study procedures including assisting to clinics, fasting before blood samples and signing a written consent

Exclusion Criteria:

• High levels of low-density lipoprotein cholesterol (LDL-C)

• Unstable cardiovascular condition or awaiting a myocardial revascularization

• Congestive cardiac failure

• Uncontrolled diabetes

• Cancer

• Uncontrolled hypothyroidism

• Familial hypercholesterolemia

• Liver/muscle disease

• Pregnancy

• Other

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemia Type II
• Hyperlipoproteinemia Type IIb
• Hyperlipoproteinemia Type IV
• Hyperlipoproteinemia Type V
• Hyperlipoproteinemias
• Hypertriglyceridemia

Intervention

Drug:
• rosuvastatin
10mg or 20mg

Locations

Country	Name	City	State
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Mexico City	DF
Mexico	Research Site	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)	Reduction from baseline to end of study	8 weeks	No
Secondary	Non-HDL-C Reduction	Reduction from baseline to end of study	8 weeks	No
Secondary	LDL-C Reduction	Reduction from baseline to end of study	8 weeks	No
Secondary	Total Cholesterol Reduction	Reduction from baseline to end of study	8 weeks	No
Secondary	HDL-C Increase	Increase from baseline to end of study	8 weeks	No
Secondary	ApoA1 Levels	Change in the levels from baseline to end of study	8 weeks	No
Secondary	hsCRP Reduction	Reduction from baseline to end of study	8 weeks	No
Secondary	Adverse Events Reported	Number of participants with AEs and SAEs reported	8 weeks	Yes
Secondary	ApoB Levels	Change in the levels from baseline to end of study	8 weeks	No