MedDataX Logo

Type III Dysbetalipoproteinemia

NCT ID: NCT00214604

Last Updated: 2010-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluation of the efficacy of rosuvastatin 10mg, rosuvastatin 20mg and pravastatin 40mg in subjects with dysbetalipoproteinemia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperlipoproteinemia Type III

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rosuvastatin

10mg

Intervention Type DRUG

rosuvastatin

20mg

Intervention Type DRUG

pravastatin

40mg

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Crestor Crestor Pravachol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of dysbetalipoproteinemia defined as VLDL-C/VLDL-TG mass ratio \>0.35 at Visit 2 or the concurrence of mixed hyperlipidemia (fasting TC ≥ 200mg/dL, fasting TG ≥ 200mg/dL at Visits 2 and 3) and a genotype of ApoE published to be associated with dysbetalipoproteinemia

Exclusion Criteria

* Use of cholesterol-lowering drugs, lipid lowering dietary supplements or food additives after Visit 1 except in accordance with the protocol as co-administered therapy (i.e., a fenofibrate) with rosuvastatin 40mg at Weeks 30 to 36; current active liver disease or hepatic dysfunction, serum CK ≥ 3 times ULN (unless explained by exercise) anytime during dietary period, serum creatinine \> 2.0 mg/dL or a history of renal transplantation before the treatment phase, fasting triglyceride \> 1000 mg/dL at any time during the dietary lead-in or a history of pancreatitis while on treatment for dysbetalipoproteinemia.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

AstraZeneca Crestor Medical Sciences Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Oslo, , Norway

Site Status

Research Site

Cape Town, , South Africa

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway South Africa

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D3560C00071

Identifier Type: -

Identifier Source: org_study_id