EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

Effect of rosuvastatin on triglyceride levels in Mexican hypertriglyceridemic patients

Research Site

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

Age Continuous

Gender, Male/Female

Arterial Hypertension

Study Specific Characteristic

Diabetes mellitus

Body mass index continuous

HDL-C levels, continuous

LDL-C, continuous

TG levels, continuous

Change (reduction) in triglycerides levels from baseline to end of treatment (week 8)

non-HDL-C reduction

LDL-C reduction

Total Cholesterol reduction

HDL-C increase

Change in the levels from baseline to end of study

ApoA1 levels

hsCRP reduction

Number of participants with AEs and SAEs reported

Adverse Events reported

ApoB levels

Overall Study

Participants with informed consent signed, and all inclusion criteria with no exclusion criteria, entered the lead in period, where they received a low fat diet. After 4 weeks if they still had TGs above 200 mg/dl they entered the randomization phase.

Effect of rosuvastatin on triglyceride levels in Mexican hypertriglyceridemic patients

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=453&filename=CSP-DM-CRESTOR-0002.pdf

CSR-D3560L00075

CSP-DM-CRESTOR-0002.pdf

CSR-D3560L00075.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator