NCT01446679

Brief Summary

This study is to evaluate the controlling effect of atrovastatin on plasma lipid to achieve the category-specific targeted lipid levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24,050

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

February 21, 2013

Status Verified

February 1, 2013

Enrollment Period

1.5 years

First QC Date

September 22, 2011

Last Update Submit

February 20, 2013

Conditions

Hypercholesterolemia

Keywords

LipitorHMG-CoA reductase inhibitor

Outcome Measures

Primary Outcomes (2)

  • Changes in plasma LDL-C concentration

    0, 4, 12 and 24 week

  • Change in rate of achievement of the category-specific target LDL-C level

    0, 4, 12 and 24 week

Secondary Outcomes (2)

  • Change in plasma lipid values (LDL cholesterol, HDL cholesterol, triglycerides, total cholesterol, and malondialdehyde-modified LDL [MDL-LDL])

    0, 4, 12 and 24 week

  • Changes in renal function test values (urinary albumin, urinary creatinine, urinary protein, and serum creatinine)

    0, 4, 12 and 24 week

Study Arms (1)

atrovastatin group

Who receive atrovastatin

Drug: atrovastatin

Interventions

atrovastatinDRUG

oral

Also known as: Lipitor
atrovastatin group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hypercholesterolemia who have not achieved the category-specific target lipid level in other statin therapies

Patients with hypercholesterolemia who have not achieved the category-specific target lipid level

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Use Central Contract

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2011

First Posted

October 5, 2011

Study Start

September 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

February 21, 2013

Record last verified: 2013-02

Locations

JP(8)