HypertriglyceridemiaPhase 4NCT00473655

Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients

A Phase 4 study testing rosuvastatin in people with Hypertriglyceridemia and Hyperlipoproteinemia Type IV, run by AstraZeneca at 3 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertriglyceridemia, Hyperlipoproteinemia Type IV, Hyperlipoproteinemia Type V
What is being tested?: rosuvastatin
How many people: 334 participants
Where: 3 sitesMexico
Study dates: Jan 2007to Feb 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

Familial hypercholesterolemia
Liver/muscle disease
Pregnancy
Other

Trial locations and contacts

3 sites in 1 country.

Mexico3 sites

Research Site
Guadalajara, Jalisco
Research Site
Mexico City, Mexico City
Research Site
Monterrey, Nuevo León

Other trials in Mexico

About this study

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

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.

Conditions: Hypertriglyceridemia, Hyperlipoproteinemia Type IV, Hyperlipoproteinemia Type V, Hyperlipoproteinemia Type IIb, Hyperlipidemia
Being tested: rosuvastatin
Keywords: Triglycerides, hypertriglyceridemia, statins, rosuvastatin, hyperlipoproteinemia, Fredrickson Type IIb or IV
Medical subject headings: Hypertriglyceridemia, Hyperlipoproteinemia Type IV, Hyperlipoproteinemia Type V, Hyperlipoproteinemia Type II, Hyperlipidemias, Hyperlipoproteinemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rosuvastatinDrug
10mg or 20mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)
Reduction from baseline to end of study
Measured: 8 weeks

Secondary outcomes (8)

Non-HDL-C Reduction
Reduction from baseline to end of study
Measured: 8 weeks
LDL-C Reduction
Reduction from baseline to end of study
Measured: 8 weeks
Total Cholesterol Reduction
Reduction from baseline to end of study
Measured: 8 weeks
HDL-C Increase
Increase from baseline to end of study
Measured: 8 weeks
ApoA1 Levels
Change in the levels from baseline to end of study
Measured: 8 weeks
hsCRP Reduction
Reduction from baseline to end of study
Measured: 8 weeks
Adverse Events Reported
Number of participants with AEs and SAEs reported
Measured: 8 weeks
ApoB Levels
Change in the levels from baseline to end of study
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Feb 2009

First posted15 May 2007 (estimated)
Study startJan 2007
Primary completionFeb 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 334 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00473655
Sponsor's protocol ID: DM-CRESTOR-0002
Status last verified: Nov 2010
First submitted: 14 May 2007
Last updated: 16 Dec 2010
Results posted: Yes, on ClinicalTrials.gov

Publications

Talavera JO, Martinez G, Cervantes JL, Marin JA, Rodriguez-Briones I, Gonzalez JG, Ocampo R, Sanchez-Mijangos H, Bernal-Rosales LP, Polanco A. A double-blind, double-dummy, randomized, placebo-controlled trial to evaluate the effect of statin therapy on triglyceride levels in Mexican hypertriglyceridemic patients. Curr Med Res Opin. 2013 Apr;29(4):379-86. doi: 10.1185/03007995.2013.766590. Epub 2013 Feb 21.
PubMed 23323877

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertriglyceridemia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00473655
Acronym / sponsor ID: DM-CRESTOR-0002
Conditions: Hypertriglyceridemia, Hyperlipoproteinemia Type IV, Hyperlipoproteinemia Type V, Hyperlipoproteinemia Type IIb, Hyperlipidemia
Keywords: Triglycerides, hypertriglyceridemia, statins, rosuvastatin, hyperlipoproteinemia, Fredrickson Type IIb or IV
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 334 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 15 May 2007 (estimated)
Results: Posted 8 Jun 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (10 listed)

High levels of low-density lipoprotein cholesterol (LDL-C)
Unstable cardiovascular condition or awaiting a myocardial revascularization
Congestive cardiac failure
Uncontrolled diabetes
Cancer

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rosuvastatin10mg or 20mg	Drug	–

Primary outcome

Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)
Time frame: 8 weeks
Reduction from baseline to end of study

8 secondary outcomes

Non-HDL-C Reduction
Time frame: 8 weeks
LDL-C Reduction
Time frame: 8 weeks
Total Cholesterol Reduction
Time frame: 8 weeks
HDL-C Increase
Time frame: 8 weeks
ApoA1 Levels
Time frame: 8 weeks
hsCRP Reduction
Time frame: 8 weeks
Adverse Events Reported
Time frame: 8 weeks
ApoB Levels
Time frame: 8 weeks

Results and safety

Results posted to the registry on 8 Jun 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rosuvastatin 10 mg	111	102
Rosuvastatin 20 mg	112	107
Placebo	111	103

Primary outcome: Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)

Time frame: 8 weeks. Mean (Standard Deviation). Unit: mg/dL

Measure	Rosuvastatin 10 mg n = 101	Rosuvastatin 20 mg n = 107	Placebo n = 103
Value	67.95 (128.46)	78.61 (121.51)	22.31 (120.54)

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rosuvastatin 10 mg	1 of 111 (0.9%)	9 of 111 (8.1%)	Not reported
Rosuvastatin 20 mg	0 of 112 (0%)	12 of 112 (10.7%)	Not reported
Placebo	0 of 111 (0%)	12 of 111 (10.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23323877Talavera JO, Martinez G, Cervantes JL, Marin JA, Rodriguez-Briones I, Gonzalez JG, Ocampo R, Sanchez-Mijangos H, Bernal-Rosales LP, Polanco A. A double-blind, double-dummy, randomized, placebo-controlled trial to evaluate the effect of statin therapy on triglyceride levels in Mexican hypertriglyceridemic patients. Curr Med Res Opin. 2013 Apr;29(4):379-86. doi: 10.1185/03007995.2013.766590. Epub 2013 Feb 21.

Related trials for Hypertriglyceridemia

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Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ana Polanco, MD study director

AstraZeneca Mexico

Ana Polanco, MD study chair

AstraZeneca Mexico

Juan Talavera, MD principal investigator

IMSS

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rosuvastatin in people with Hypertriglyceridemia and Hyperlipoproteinemia Type IV, run by AstraZeneca at 3 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00473655, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2010.