Clinical Trials Logo
  1. Home
  2. Dyslipidemia
  3. NCT01164397
  4. Details
NCT01164397 Clinical Trial

Efficiency of Rosuvastatin Versus the Fixed Combination of Ezetimibe/Simvastatin in Outpatients

Dyslipidemia Clinical Trial

Official title:
Efficiency of Rosuvastatin Versus the Fixed Combination of Ezetimibe/Simvastatin to Reduce the Cholesterol Levels in Outpatients in a Realistic Environment. A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01164397
Other study ID # NIS-CME-CRE-2010/1
Secondary ID DM-CRESTOR-0003
Status Completed
Phase N/A
First received May 28, 2010
Last updated January 17, 2012
Start date April 2009
Est. completion date December 2010

Study information
Verified date January 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Mexico: Ethics Committee
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the effectiveness of Rosuvastatin versus Ezetimibe/Simvastatin in dyslipidemic patients treated for at least 8 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 268
Est. completion date December 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Dislipidemic population treated with rosuvastatin or ezetimibe/simvastatin for at least for 8 weeks

- Who have completed at least 80% of the treatment

- To have determinations at least of CT, TG C-LDL and CHDL before starting treatment and after 8 weeks of taking the medicine

Exclusion Criteria:

- Initiating different therapy lipid lowering to Rosuvastatin or Ezetimibe/Simvastatin

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Mexico Research Site Cuernavaca Morelos
Mexico Research Site Durango
Mexico Research Site Guadalajara Jalisco
Mexico Research Site Merida Yucatan
Mexico Research Site Mexico DF
Mexico Research Site Monterrey Nuevo Leon
Mexico Research Site Puebla
Mexico Research Site San Luis Potosi
Mexico Research Site Veracruz Xalapa

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary The percentage of the patients that achieve the goal proposed for NCEP ATP III (2001 y 2004) will be assessed, to C-LDL in patients treated with Rosuvastatin or Ezetimibe/Simvastatin at least for 8 weeks. Data will be collected using CRFs after complete at least 15 patients over a 24 week period. Yes
Secondary The percentage of LDL-C reduction according to baseline levels in patients treated wuth Rosuvastatin or Ezetimibe/Simvastatin for at least 8 weeks. Data will be collected using CRFs after complete at least 15 patients over a 24 week period. Yes
See also
  Status Clinical Trial Phase
Completed NCT00001154 - Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
Not yet recruiting NCT06405880 - Pharmacist Case Finding and Intervention for Vascular Prevention Trial N/A
Recruiting NCT02837367 - Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People N/A
Active, not recruiting NCT02223793 - Vascular Lifestyle-Intervention and Screening in Pharmacy N/A
Active, not recruiting NCT02600338 - Meta-analyses of the Effect of Legumes on Blood Pressure N/A
Completed NCT02163044 - The Hellenic Postprandial Lipemia Study (HPLS)
Recruiting NCT01972113 - Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study) N/A
Recruiting NCT01705873 - Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen N/A
Completed NCT01764295 - Clinical Study for Patients With Hypertension Associated With Dyslipidemia Phase 3
Terminated NCT01414166 - Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108) Phase 3
Completed NCT01990391 - Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities N/A
Completed NCT01531062 - Effect of Nigella Sativa on Lipid Profiles in Elderly Phase 2
Recruiting NCT01670968 - HIV Reverse Cholesterol Transport Study
Completed NCT00977288 - A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029) Phase 2
Withdrawn NCT00664287 - Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082) Phase 3
Completed NCT00768274 - Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol Phase 1/Phase 2
Completed NCT01285544 - The Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia Phase 4
Completed NCT00300430 - Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia. Phase 3
Completed NCT01483235 - Reduced Cardiac Rehabilitation Program N/A
Completed NCT00309738 - Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin Phase 3